{"protocolSection":{"identificationModule":{"nctId":"NCT00734474","orgStudyIdInfo":{"id":"11422"},"secondaryIdInfos":[{"id":"H9X-MC-GBCF","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"CTRI/2009/091/000969","type":"REGISTRY","domain":"Clinical Trials Registry - India"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin","officialTitle":"A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-08"},"primaryCompletionDateStruct":{"date":"2011-06","type":"ACTUAL"},"completionDateStruct":{"date":"2012-07","type":"ACTUAL"},"studyFirstSubmitDate":"2008-08-12","studyFirstSubmitQcDate":"2008-08-12","studyFirstPostDateStruct":{"date":"2008-08-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-03","resultsFirstSubmitQcDate":"2015-01-26","resultsFirstPostDateStruct":{"date":"2015-01-28","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-09-20","dispFirstSubmitQcDate":"2011-09-20","dispFirstPostDateStruct":{"date":"2011-09-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-31","lastUpdatePostDateStruct":{"date":"2015-04-20","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"United BioSource, LLC","class":"INDUSTRY"},{"name":"Tessella Inc.","class":"INDUSTRY"},{"name":"Berry Consultants","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.","detailedDescription":"This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to 26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3 portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if 2 doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin (HbA1c) at 52 weeks. The final endpoint is 104 weeks.\n\nParticipants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265 doses until a dose decision is made based on quantitative analysis of the benefits and risks of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this end. After the dose decision, participants in the selected LY2189265 arms and the comparator arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional participants will be randomized to the selected and comparator arms. Regardless of the timing of randomization relative to the dose decision point, all participants in the selected and comparator arms are planned to receive treatment for 104 weeks; participants in the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain blinded to their study treatment throughout the study. Participants in the non-selected arms will discontinue from the study after the dose decision"},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["Diabetes, type 2 diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1202,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"3.0 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"2.0 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"1.5 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"1.0 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"0.75 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"0.5 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"0.25 mg LY2189265","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks","interventionNames":["Drug: LY2189265","Drug: Placebo tablet","Drug: Metformin"]},{"label":"Sitagliptin","type":"ACTIVE_COMPARATOR","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks","interventionNames":["Drug: Sitagliptin","Drug: Placebo solution","Drug: Metformin"]},{"label":"Placebo/Sitagliptin (Baseline Through 104 Weeks)","type":"PLACEBO_COMPARATOR","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks","interventionNames":["Drug: Placebo solution","Drug: Placebo tablet","Drug: Metformin"]}],"interventions":[{"type":"DRUG","name":"LY2189265","armGroupLabels":["0.25 mg LY2189265","0.5 mg LY2189265","0.75 mg LY2189265","1.0 mg LY2189265","1.5 mg LY2189265","2.0 mg LY2189265","3.0 mg LY2189265"],"otherNames":["Dulaglutide","Trulicity"]},{"type":"DRUG","name":"Sitagliptin","armGroupLabels":["Sitagliptin"]},{"type":"DRUG","name":"Placebo solution","armGroupLabels":["Placebo/Sitagliptin (Baseline Through 104 Weeks)","Sitagliptin"]},{"type":"DRUG","name":"Placebo tablet","armGroupLabels":["0.25 mg LY2189265","0.5 mg LY2189265","0.75 mg LY2189265","1.0 mg LY2189265","1.5 mg LY2189265","2.0 mg LY2189265","3.0 mg LY2189265","Placebo/Sitagliptin (Baseline Through 104 Weeks)"]},{"type":"DRUG","name":"Metformin","armGroupLabels":["0.25 mg LY2189265","0.5 mg LY2189265","0.75 mg LY2189265","1.0 mg LY2189265","1.5 mg LY2189265","2.0 mg LY2189265","3.0 mg LY2189265","Placebo/Sitagliptin (Baseline Through 104 Weeks)","Sitagliptin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Glycosylated Hemoglobin (HbA1c) Change From Baseline","description":"Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.","timeFrame":"Baseline, 52 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point","description":"Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.","timeFrame":"Baseline up to 27.4 weeks"},{"measure":"Glycosylated Hemoglobin (HbA1c) Change From Baseline","description":"Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.","timeFrame":"Baseline, 26 weeks, 104 weeks"},{"measure":"Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)","description":"Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 13, 26, 52, and 104 weeks"},{"measure":"Fasting Blood Glucose Change From Baseline","description":"Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 104 weeks"},{"measure":"Fasting Insulin Change From Baseline","description":"Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 104 weeks"},{"measure":"Change From Baseline in Body Weight at Dose Decision Point","description":"Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.","timeFrame":"Baseline up to 27.4 weeks"},{"measure":"Body Weight Change From Baseline","description":"Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 104 weeks"},{"measure":"Durability of Change From Baseline Body Weight","description":"Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 13, 26, 52, and 104 weeks"},{"measure":"Waist Circumference Change From Baseline","description":"Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 104 weeks"},{"measure":"Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%","description":"The percentage of participants achieving HbA1c levels \\<7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.","timeFrame":"Baseline, 26, 52, and 104 weeks"},{"measure":"Incidence of Hypoglycemic Episodes","description":"Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter \\[mmol/L\\]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.","timeFrame":"Baseline through 26 and 104 weeks"},{"measure":"Rate of Hypoglycemic Episodes","description":"Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter \\[mmol/L\\]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.","timeFrame":"Baseline through 26 and 104 weeks"},{"measure":"Beta Cell Function and Insulin Sensitivity (HOMA2)","description":"The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 104 weeks"},{"measure":"Number of Participants With Treatment-emergent Adverse Events at 26 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 26 weeks"},{"measure":"Number of Participants With Treatment-emergent Adverse Events at 52 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 52 weeks"},{"measure":"Number of Participants With Treatment-emergent Adverse Events at 104 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 104 weeks"},{"measure":"Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks","description":"The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).","timeFrame":"Baseline through 26 weeks"},{"measure":"Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks","description":"The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .","timeFrame":"Baseline through 52 weeks"},{"measure":"Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks","description":"The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).","timeFrame":"Baseline through 104 weeks"},{"measure":"Number of Participants With Treatment-emergent Abnormal Lipid Tests","description":"The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol \\[HDL-C\\], low density lipoprotein cholesterol \\[LDL-C\\], and triglycerides \\[TG\\]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.","timeFrame":"Baseline through 26 and 104 weeks"},{"measure":"Change From Baseline in Pulse Rate at Dose Decision Point","description":"Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.","timeFrame":"Baseline up to 27.4 weeks"},{"measure":"Change From Baseline in Blood Pressure at Dose Decision Point","description":"Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.","timeFrame":"Baseline up to 27.4 weeks"},{"measure":"Change From Baseline in Pulse Rate","description":"Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.","timeFrame":"Baseline, 26 weeks, 104 weeks"},{"measure":"Change From Baseline in Blood Pressure","description":"Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26 weeks, 104 weeks"},{"measure":"Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval","description":"The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26 weeks, 104 weeks"},{"measure":"Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)","description":"The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants' quality of life. Items are scored on a 5-point numeric rating scale where 5 = \"always true\" and 1 = \"never true\". Items are summed into 6 scales (physical function \\[11 items\\], self-esteem \\[7 items\\], sexual life \\[4 items\\], public distress \\[5 items\\], work \\[4 items\\], and total score \\[31 items\\]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.","timeFrame":"Baseline, 52 weeks, and 104 weeks"},{"measure":"Participant-reported Outcomes, EQ-5D","description":"The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).","timeFrame":"Baseline, 52 weeks, and 104 weeks"},{"measure":"Resource Utilization","description":"The number of visits to the emergency room (ER) is summarized cumulatively.","timeFrame":"Baseline through 52 and 104 weeks"},{"measure":"Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve","description":"Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.","timeFrame":"Baseline through 52 weeks"},{"measure":"Antibodies to LY2189265","description":"The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.","timeFrame":"Baseline through 104 weeks"}],"otherOutcomes":[{"measure":"Number of Participants With Adjudicated Pancreatitis at 104 Weeks","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 104 weeks"},{"measure":"Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks","description":"Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 104 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diabetes mellitus, type 2, for at least 6 months\n* Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.\n* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of \\>8.0% to ≤9.5%\n* Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m\\^2), inclusive\n* Stable weight for 3 months prior to screening\n* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method\n\nExclusion Criteria:\n\n* Diabetes mellitus, type 1\n* Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin\n* Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility\n* Use of medications to promote weight loss\n* Clinically-relevant cardiovascular event within 6 months prior to screening\n* Poorly controlled hypertension\n* Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease\n* Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels \\>3.0 times the upper limit of normal\n* Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance \\<60 milliliters per minute (mL/minute)\n* Uncontrolled diabetes, defined as \\>2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.\n* Uncontrolled endocrine or autoimmune abnormality\n* History of a transplanted organ\n* Chronic use of systemic glucocorticoid therapy\n* Active or untreated malignancy\n* Use of central nervous system (CNS) stimulants","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_CHAIR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Phoenix","state":"Arizona","zip":"85050","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tucson","state":"Arizona","zip":"85741","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fresno","state":"California","zip":"93726","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mission Hills","state":"California","zip":"91345","country":"United States","geoPoint":{"lat":34.68609,"lon":-120.43683}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Longmont","state":"Colorado","zip":"80501","country":"United States","geoPoint":{"lat":40.16721,"lon":-105.10193}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hollywood","state":"Florida","zip":"33021","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"West Palm Beach","state":"Florida","zip":"33401","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Athens","state":"Georgia","zip":"30606","country":"United States","geoPoint":{"lat":33.96095,"lon":-83.37794}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Atlanta","state":"Georgia","zip":"30303","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Springfield","state":"Illinois","zip":"62704","country":"United States","geoPoint":{"lat":39.80172,"lon":-89.64371}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Metairie","state":"Louisiana","zip":"70006","country":"United States","geoPoint":{"lat":29.98409,"lon":-90.15285}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Biddeford","state":"Maine","zip":"04005","country":"United States","geoPoint":{"lat":43.49258,"lon":-70.45338}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ann Arbor","state":"Michigan","zip":"48106","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint Clair Shores","state":"Michigan","zip":"48081","country":"United States","geoPoint":{"lat":42.49698,"lon":-82.88881}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Southfield","state":"Michigan","zip":"48075","country":"United States","geoPoint":{"lat":42.47337,"lon":-83.22187}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Billings","state":"Montana","zip":"59101","country":"United States","geoPoint":{"lat":45.78329,"lon":-108.50069}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Las Vegas","state":"Nevada","zip":"89101","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Rochester","state":"New York","zip":"14607","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Greensboro","state":"North Carolina","zip":"27401","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Morehead City","state":"North Carolina","zip":"28557","country":"United States","geoPoint":{"lat":34.72294,"lon":-76.72604}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Corvallis","state":"Oregon","zip":"97330","country":"United States","geoPoint":{"lat":44.56457,"lon":-123.26204}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Charleston","state":"South Carolina","zip":"29412","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Georgetown","state":"Texas","zip":"78626","country":"United States","geoPoint":{"lat":30.63269,"lon":-97.67723}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Federal Way","state":"Washington","zip":"98003","country":"United States","geoPoint":{"lat":47.32232,"lon":-122.31262}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tacoma","state":"Washington","zip":"98405","country":"United States","geoPoint":{"lat":47.25288,"lon":-122.44429}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Calgary","state":"Alberta","zip":"T2H 2G4","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Winnipeg","state":"Manitoba","zip":"R3P 3P4","country":"Canada","geoPoint":{"lat":49.8844,"lon":-97.14704}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Oakville","state":"Ontario","zip":"L6H 3P1","country":"Canada","geoPoint":{"lat":43.45011,"lon":-79.68292}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Sherbrooke","state":"Quebec","zip":"J1G 5K2","country":"Canada","geoPoint":{"lat":45.40008,"lon":-71.89908}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Corbeil-Essonnes","zip":"91106","country":"France","geoPoint":{"lat":48.60603,"lon":2.48757}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"La Rochelle","zip":"17019","country":"France","geoPoint":{"lat":46.16308,"lon":-1.15222}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mantes-la-Jolie","zip":"78200","country":"France","geoPoint":{"lat":48.99048,"lon":1.7167}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Montpellier","zip":"F-34295","country":"France","geoPoint":{"lat":43.61093,"lon":3.87635}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Narbonne","zip":"11108","country":"France","geoPoint":{"lat":43.18396,"lon":3.00141}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint-Mandé","zip":"94160","country":"France","geoPoint":{"lat":48.83864,"lon":2.41579}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Strasbourg","zip":"67000","country":"France","geoPoint":{"lat":48.58392,"lon":7.74553}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Toul","zip":"54201","country":"France","geoPoint":{"lat":48.68075,"lon":5.89115}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Vénissieux","zip":"69200","country":"France","geoPoint":{"lat":45.69706,"lon":4.88593}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aschaffenburg","zip":"63739","country":"Germany","geoPoint":{"lat":49.97704,"lon":9.15214}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bad Lauterberg im Harz","zip":"D-37431","country":"Germany","geoPoint":{"lat":51.63272,"lon":10.47031}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bad Staffelstein","zip":"D-96231","country":"Germany","geoPoint":{"lat":50.10199,"lon":11.00128}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bochum","zip":"D-44791","country":"Germany","geoPoint":{"lat":51.48165,"lon":7.21648}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Essen","zip":"45355","country":"Germany","geoPoint":{"lat":51.45657,"lon":7.01228}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hamburg","zip":"21073","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hirschhorn","zip":"69434","country":"Germany","geoPoint":{"lat":49.44566,"lon":8.89594}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mainz","zip":"D-55116","country":"Germany","geoPoint":{"lat":49.98185,"lon":8.28008}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Münster","zip":"48145","country":"Germany","geoPoint":{"lat":51.96236,"lon":7.62571}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Neuwied","zip":"56564","country":"Germany","geoPoint":{"lat":50.4336,"lon":7.47057}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Pohlheim","zip":"D-35415","country":"Germany"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Rotenburg-Fulda","zip":"36199","country":"Germany"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ahmedabad","zip":"380006","country":"India","geoPoint":{"lat":23.02579,"lon":72.58727}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bangalore","zip":"560038","country":"India","geoPoint":{"lat":12.97194,"lon":77.59369}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ghaziabad","zip":"201 002","country":"India","geoPoint":{"lat":28.66535,"lon":77.43915}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kochi","zip":"682026","country":"India","geoPoint":{"lat":9.93988,"lon":76.26022}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Pune","zip":"411005","country":"India","geoPoint":{"lat":18.51957,"lon":73.85535}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aguascalientes","zip":"20129","country":"Mexico","geoPoint":{"lat":21.88262,"lon":-102.2843}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chihuahua City","zip":"31238","country":"Mexico","geoPoint":{"lat":28.63528,"lon":-106.08889}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Guadalajara","zip":"44600","country":"Mexico","geoPoint":{"lat":20.67738,"lon":-103.34749}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Monterrey","zip":"64461","country":"Mexico","geoPoint":{"lat":25.68435,"lon":-100.31721}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Gdynia","zip":"81-557","country":"Poland","geoPoint":{"lat":54.51889,"lon":18.53188}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lodz","zip":"93-319","country":"Poland","geoPoint":{"lat":51.77058,"lon":19.47395}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lublin","zip":"20-954","country":"Poland","geoPoint":{"lat":51.25058,"lon":22.57009}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Szczecin","zip":"70-506","country":"Poland","geoPoint":{"lat":53.42894,"lon":14.55302}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Wroclaw","zip":"50-403","country":"Poland","geoPoint":{"lat":51.10286,"lon":17.03006}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Manati","zip":"00674","country":"Puerto Rico","geoPoint":{"lat":18.42745,"lon":-66.49212}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"San Juan","zip":"00907","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Baia Mare","zip":"430123","country":"Romania","geoPoint":{"lat":47.65729,"lon":23.56808}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Cluj-Napoca","zip":"400006","country":"Romania","geoPoint":{"lat":46.76667,"lon":23.6}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Timișoara","zip":"300736","country":"Romania","geoPoint":{"lat":45.75372,"lon":21.22571}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Arkhangelsk","zip":"163045","country":"Russia","geoPoint":{"lat":64.5461,"lon":40.55183}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Rostov-on-Don","zip":"344022","country":"Russia","geoPoint":{"lat":47.21997,"lon":39.70769}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint Petersburg","zip":"193257","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Goyang-si","zip":"410-719","country":"South Korea","geoPoint":{"lat":37.65639,"lon":126.835}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Incheon","zip":"400-711","country":"South Korea","geoPoint":{"lat":37.45646,"lon":126.70515}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Seongnam-si","zip":"463-707","country":"South Korea","geoPoint":{"lat":37.43861,"lon":127.13778}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Seoul","zip":"139-872","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Sungnam-Si","zip":"463-712","country":"South Korea"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Dos Hermanas","zip":"41014","country":"Spain","geoPoint":{"lat":37.28287,"lon":-5.92088}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lleida","zip":"25198","country":"Spain","geoPoint":{"lat":41.61674,"lon":0.62218}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Málaga","zip":"29010","country":"Spain","geoPoint":{"lat":36.72016,"lon":-4.42034}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Palma de Mallorca","zip":"07010","country":"Spain","geoPoint":{"lat":39.56939,"lon":2.65024}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Pozuelo de Alarcón","zip":"28223","country":"Spain","geoPoint":{"lat":40.43293,"lon":-3.81338}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chiayi City","zip":"600","country":"Taiwan","geoPoint":{"lat":23.47917,"lon":120.44889}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kaohsiung City","zip":"807","country":"Taiwan","geoPoint":{"lat":22.61626,"lon":120.31333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Taichung","zip":"40201","country":"Taiwan","geoPoint":{"lat":24.1469,"lon":120.6839}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Taichung","zip":"407","country":"Taiwan","geoPoint":{"lat":24.1469,"lon":120.6839}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tainan","zip":"70403","country":"Taiwan","geoPoint":{"lat":22.99083,"lon":120.21333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Taipei","zip":"100","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Yung-Kang, Tainan","zip":"710","country":"Taiwan","geoPoint":{"lat":22.99083,"lon":120.21333}}]},"referencesModule":{"references":[{"pmid":"36894938","type":"DERIVED","citation":"Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x."},{"pmid":"28755389","type":"DERIVED","citation":"Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437."},{"pmid":"27161178","type":"DERIVED","citation":"Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7."},{"pmid":"26691396","type":"DERIVED","citation":"Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4."},{"pmid":"25912221","type":"DERIVED","citation":"Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20."},{"pmid":"24762094","type":"DERIVED","citation":"Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22."},{"pmid":"23294774","type":"DERIVED","citation":"Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608."}],"seeAlsoLinks":[{"label":"(Lilly Clinical Trial Registry)","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"FG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"FG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"FG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"FG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"FG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"FG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"FG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"FG008","title":"Placebo/Sitagliptin","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"periods":[{"title":"Overall 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continued the study after the dose decision point (selected arm).","numSubjects":"21"},{"groupId":"FG005","comment":"These participants discontinued the study after the dose decision point.","numSubjects":"21"},{"groupId":"FG006","comment":"These participants discontinued the study after the dose decision point.","numSubjects":"23"},{"groupId":"FG007","comment":"These participants continued the study after the dose decision point (comparator arm).","numSubjects":"42"},{"groupId":"FG008","comment":"These participants continued the study after the dose decision point (comparator arm).","numSubjects":"34"}]},{"type":"Entered Study After Dose Decision 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Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"BG001","title":"2.0 mg LY2189265","description":"LY2189265 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Republic of","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"25"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"31"},{"groupId":"BG008","value":"15"},{"groupId":"BG009","value":"105"}]}]}]},{"title":"Body 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(kg/m^2)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.02","spread":"4.69"},{"groupId":"BG001","value":"31.45","spread":"4.88"},{"groupId":"BG002","value":"31.40","spread":"4.57"},{"groupId":"BG003","value":"33.89","spread":"4.44"},{"groupId":"BG004","value":"31.15","spread":"4.44"},{"groupId":"BG005","value":"32.53","spread":"4.61"},{"groupId":"BG006","value":"31.06","spread":"3.94"},{"groupId":"BG007","value":"31.02","spread":"4.20"},{"groupId":"BG008","value":"31.37","spread":"4.25"},{"groupId":"BG009","value":"31.27","spread":"4.39"}]}]}]},{"title":"Glycosylated Hemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of glycosylated hemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.95","spread":"1.11"},{"groupId":"BG001","value":"8.36","spread":"1.04"},{"groupId":"BG002","value":"8.12","spread":"1.05"},{"groupId":"BG003","value":"7.87","spread":"0.62"},{"groupId":"BG004","value":"8.19","spread":"1.11"},{"groupId":"BG005","value":"8.30","spread":"1.34"},{"groupId":"BG006","value":"7.82","spread":"0.80"},{"groupId":"BG007","value":"8.09","spread":"1.09"},{"groupId":"BG008","value":"8.10","spread":"1.14"},{"groupId":"BG009","value":"8.13","spread":"1.09"}]}]}]},{"title":"Duration of Diabetes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.79","spread":"6.34"},{"groupId":"BG001","value":"6.92","spread":"5.12"},{"groupId":"BG002","value":"6.95","spread":"5.50"},{"groupId":"BG003","value":"7.04","spread":"4.57"},{"groupId":"BG004","value":"7.34","spread":"4.92"},{"groupId":"BG005","value":"6.75","spread":"3.99"},{"groupId":"BG006","value":"6.74","spread":"4.20"},{"groupId":"BG007","value":"7.16","spread":"4.89"},{"groupId":"BG008","value":"6.96","spread":"5.43"},{"groupId":"BG009","value":"7.09","spread":"5.12"}]}]}]},{"title":"Fasting Plasma Glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"millimoles per liter (mmol/L)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"NA","spread":"NA","comment":"Baseline fasting plasma glucose was not summarized for this treatment arm."},{"groupId":"BG001","value":"NA","spread":"NA","comment":"Baseline fasting plasma glucose was not summarized for this treatment arm."},{"groupId":"BG002","value":"9.75","spread":"3.27"},{"groupId":"BG003","value":"NA","spread":"NA","comment":"Baseline fasting plasma glucose was not summarized for this treatment arm."},{"groupId":"BG004","value":"9.68","spread":"2.94"},{"groupId":"BG005","value":"NA","spread":"NA","comment":"Baseline fasting plasma glucose was not summarized for this treatment arm."},{"groupId":"BG006","value":"NA","spread":"NA","comment":"Baseline fasting plasma glucose was not summarized for this treatment arm."},{"groupId":"BG007","value":"9.56","spread":"2.80"},{"groupId":"BG008","value":"9.86","spread":"3.15"},{"groupId":"BG009","value":"NA","spread":"NA","comment":"Total Mean (SD) were not calculated for this baseline measure."}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Glycosylated Hemoglobin (HbA1c) Change From 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Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 52 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"297"},{"groupId":"OG002","value":"311"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.10","spread":"0.06"},{"groupId":"OG001","value":"-0.87","spread":"0.06"},{"groupId":"OG002","value":"-0.39","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Power was estimated at approximately 89% based on a simulation study using the \"most likely\" pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Family-wise Type I error rate was controlled by applying gatekeeping strategies.","pValue":"<0.001","pValueComment":"P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.87","ciUpperLimit":"-0.55"},{"groupIds":["OG001","OG002"],"groupDescription":"Power was estimated at approximately 89% based on a simulation study using the \"most likely\" pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Family-wise Type I error rate was controlled by applying a gatekeeping strategy.","pValue":"<0.001","pValueComment":"P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"-0.31"},{"groupIds":["OG000","OG002"],"groupDescription":"Superiority analysis","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.87","ciUpperLimit":"-0.55"},{"groupIds":["OG001","OG002"],"groupDescription":"Superiority analysis","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"-0.31"}]},{"type":"SECONDARY","title":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point","description":"Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.","populationDescription":"All participants randomized before the dose decision point who had evaluable HbA1c data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline up to 27.4 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG008","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"20"},{"groupId":"OG005","value":"21"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"30"},{"groupId":"OG008","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.09","spread":"0.77"},{"groupId":"OG001","value":"-1.25","spread":"0.68"},{"groupId":"OG002","value":"-1.49","spread":"1.12"},{"groupId":"OG003","value":"-0.98","spread":"0.47"},{"groupId":"OG004","value":"-1.02","spread":"0.99"},{"groupId":"OG005","value":"-0.94","spread":"0.65"},{"groupId":"OG006","value":"-0.70","spread":"0.49"},{"groupId":"OG007","value":"-0.76","spread":"0.86"},{"groupId":"OG008","value":"-0.06","spread":"0.64"}]}]}]},{"type":"SECONDARY","title":"Glycosylated Hemoglobin (HbA1c) Change From Baseline","description":"Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 26 weeks, 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"297"},{"groupId":"OG002","value":"311"},{"groupId":"OG003","value":"176"}]}],"classes":[{"title":"26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.22","spread":"0.05"},{"groupId":"OG001","value":"-1.01","spread":"0.06"},{"groupId":"OG002","value":"-0.61","spread":"0.05"},{"groupId":"OG003","value":"0.03","spread":"0.07"}]}]},{"title":"104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-0.99","spread":"0.06"},{"groupId":"OG001","value":"-0.71","spread":"0.07"},{"groupId":"OG002","value":"-0.32","spread":"0.06"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Superiority analysis","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.42","ciUpperLimit":"-1.09"},{"groupIds":["OG001","OG003"],"groupDescription":"Superiority analysis","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.21","ciUpperLimit":"-0.88"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.81","ciUpperLimit":"-0.48"},{"groupIds":["OG000","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Family-wise Type I error rate was controlled by applying a gatekeeping strategy.","pValue":"<0.001","pValueComment":"Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.84","ciUpperLimit":"-0.50"},{"groupIds":["OG001","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Family-wise Type I error rate controlled by applying gatekeeping strategy.","pValue":"<0.001","pValueComment":"Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"-0.22"},{"groupIds":["OG000","OG002"],"groupDescription":"Superiority analysis","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.84","ciUpperLimit":"-0.50"},{"groupIds":["OG001","OG002"],"groupDescription":"Superiority analysis","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"-0.22"}]},{"type":"SECONDARY","title":"Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)","description":"Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable HbA1c data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 13, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"303"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"314"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"26 Weeks Versus 13 Weeks (n=269, 269, 276, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.04"},{"groupId":"OG001","value":"0.02","spread":"0.04"},{"groupId":"OG002","value":"0.00","spread":"0.04"},{"groupId":"OG003","value":"-0.14","spread":"0.05"}]}]},{"title":"52 Weeks Versus 26 Weeks (n=245, 254, 250)","categories":[{"measurements":[{"groupId":"OG000","value":"0.14","spread":"0.05"},{"groupId":"OG001","value":"0.16","spread":"0.05"},{"groupId":"OG002","value":"0.24","spread":"0.05"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"104 Weeks Versus 52 Weeks (n=194, 191, 190)","categories":[{"measurements":[{"groupId":"OG000","value":"0.13","spread":"0.06"},{"groupId":"OG001","value":"0.16","spread":"0.06"},{"groupId":"OG002","value":"0.09","spread":"0.06"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]}]},{"type":"SECONDARY","title":"Fasting Blood Glucose Change From Baseline","description":"Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable fasting plasma glucose data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"296"},{"groupId":"OG002","value":"308"},{"groupId":"OG003","value":"176"}]}],"classes":[{"title":"26 Weeks (n=265, 271, 276, 135)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.38","spread":"0.12"},{"groupId":"OG001","value":"-1.97","spread":"0.12"},{"groupId":"OG002","value":"-0.97","spread":"0.11"},{"groupId":"OG003","value":"-0.49","spread":"0.16"}]}]},{"title":"52 Weeks (n=239, 247, 244)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.38","spread":"0.13"},{"groupId":"OG001","value":"-1.63","spread":"0.13"},{"groupId":"OG002","value":"-0.90","spread":"0.13"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"104 Weeks (n=190, 187, 181)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.99","spread":"0.15"},{"groupId":"OG001","value":"-1.39","spread":"0.15"},{"groupId":"OG002","value":"-0.47","spread":"0.15"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Comparison at 26 weeks.","paramType":"LS Mean Difference","paramValue":"-1.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.27","ciUpperLimit":"-1.51"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.85","ciUpperLimit":"-1.10"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.012","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.86","ciUpperLimit":"-0.11"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.82","ciUpperLimit":"-1.13"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.73","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.07","ciUpperLimit":"-0.39"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.93","ciUpperLimit":"-1.10"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.33","ciUpperLimit":"-0.51"}]},{"type":"SECONDARY","title":"Fasting Insulin Change From Baseline","description":"Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable fasting insulin data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomoles per liter (pmol/L)","timeFrame":"Baseline, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"254"},{"groupId":"OG001","value":"261"},{"groupId":"OG002","value":"247"},{"groupId":"OG003","value":"122"}]}],"classes":[{"title":"26 Weeks (n=238, 249, 230, 115)","categories":[{"measurements":[{"groupId":"OG000","value":"11.59","spread":"6.57"},{"groupId":"OG001","value":"10.15","spread":"6.51"},{"groupId":"OG002","value":"8.48","spread":"6.68"},{"groupId":"OG003","value":"-6.92","spread":"9.24"}]}]},{"title":"52 Weeks (n=207, 218, 200)","categories":[{"measurements":[{"groupId":"OG000","value":"10.57","spread":"5.95"},{"groupId":"OG001","value":"12.95","spread":"5.88"},{"groupId":"OG002","value":"4.18","spread":"6.01"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"104 Weeks (n=187, 200, 183)","categories":[{"measurements":[{"groupId":"OG000","value":"11.36","spread":"7.58"},{"groupId":"OG001","value":"21.56","spread":"7.40"},{"groupId":"OG002","value":"0.29","spread":"7.64"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.095","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"18.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.25","ciUpperLimit":"40.28"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.121","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"17.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.54","ciUpperLimit":"38.69"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.167","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"15.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.47","ciUpperLimit":"37.29"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.430","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"6.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.49","ciUpperLimit":"22.26"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.273","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"8.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.94","ciUpperLimit":"24.47"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.291","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"11.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.49","ciUpperLimit":"31.64"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.039","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"21.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.03","ciUpperLimit":"41.53"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Dose Decision Point","description":"Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.","populationDescription":"All participants randomized before the dose decision point who had evaluable body weight data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline up to 27.4 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG008","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"20"},{"groupId":"OG005","value":"22"},{"groupId":"OG006","value":"17"},{"groupId":"OG007","value":"35"},{"groupId":"OG008","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.32","spread":"3.37"},{"groupId":"OG001","value":"-2.15","spread":"1.97"},{"groupId":"OG002","value":"-2.12","spread":"1.93"},{"groupId":"OG003","value":"-2.23","spread":"1.63"},{"groupId":"OG004","value":"-1.17","spread":"2.30"},{"groupId":"OG005","value":"-1.53","spread":"1.88"},{"groupId":"OG006","value":"-0.85","spread":"1.47"},{"groupId":"OG007","value":"-0.43","spread":"1.78"},{"groupId":"OG008","value":"-0.56","spread":"1.69"}]}]}]},{"type":"SECONDARY","title":"Body Weight Change From Baseline","description":"Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable body weight data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"303"},{"groupId":"OG001","value":"299"},{"groupId":"OG002","value":"314"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-3.18","spread":"0.18"},{"groupId":"OG001","value":"-2.63","spread":"0.19"},{"groupId":"OG002","value":"-1.46","spread":"0.18"},{"groupId":"OG003","value":"-1.47","spread":"0.24"}]}]},{"title":"52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-3.03","spread":"0.22"},{"groupId":"OG001","value":"-2.60","spread":"0.23"},{"groupId":"OG002","value":"-1.53","spread":"0.22"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-2.88","spread":"0.25"},{"groupId":"OG001","value":"-2.39","spread":"0.26"},{"groupId":"OG002","value":"-1.75","spread":"0.25"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.70","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.27","ciUpperLimit":"-1.14"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.73","ciUpperLimit":"-0.60"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.953","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.58"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.08","ciUpperLimit":"-0.92"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.65","ciUpperLimit":"-0.48"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.78","ciUpperLimit":"-0.49"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.054","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.29","ciUpperLimit":"0.01"}]},{"type":"SECONDARY","title":"Durability of Change From Baseline Body Weight","description":"Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable body weight data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline, 13, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"26 Weeks Versus 13 Weeks (n=271, 278, 282, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.53","spread":"0.14"},{"groupId":"OG001","value":"-0.57","spread":"0.14"},{"groupId":"OG002","value":"-0.42","spread":"0.13"},{"groupId":"OG003","value":"-0.37","spread":"0.18"}]}]},{"title":"52 Weeks Versus 26 Weeks (n=246, 255, 253)","categories":[{"measurements":[{"groupId":"OG000","value":"0.17","spread":"0.18"},{"groupId":"OG001","value":"0.06","spread":"0.18"},{"groupId":"OG002","value":"-0.04","spread":"0.18"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"104 Weeks Versus 26 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"0.42","spread":"0.23"},{"groupId":"OG001","value":"0.32","spread":"0.24"},{"groupId":"OG002","value":"-0.39","spread":"0.23"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]}]},{"type":"SECONDARY","title":"Waist Circumference Change From Baseline","description":"Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable waist circumference data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"centimeters (cm)","timeFrame":"Baseline, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"301"},{"groupId":"OG002","value":"312"},{"groupId":"OG003","value":"175"}]}],"classes":[{"title":"26 Weeks (n=266, 273, 277, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.89","spread":"0.24"},{"groupId":"OG001","value":"-1.78","spread":"0.24"},{"groupId":"OG002","value":"-1.45","spread":"0.24"},{"groupId":"OG003","value":"-1.20","spread":"0.32"}]}]},{"title":"52 Weeks (n=238, 250, 247)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.91","spread":"0.29"},{"groupId":"OG001","value":"-2.05","spread":"0.29"},{"groupId":"OG002","value":"-1.45","spread":"0.29"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"104 Weeks (n=192, 189, 188)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.57","spread":"0.35"},{"groupId":"OG001","value":"-1.75","spread":"0.35"},{"groupId":"OG002","value":"-1.20","spread":"0.35"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.69","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.45","ciUpperLimit":"-0.93"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.133","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.34","ciUpperLimit":"0.18"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.512","pValueComment":"Comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.01","ciUpperLimit":"0.50"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.23","ciUpperLimit":"-0.69"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.128","pValueComment":"Comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.36","ciUpperLimit":"0.17"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.30","ciUpperLimit":"-0.42"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.256","pValueComment":"Comparison at 104 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.48","ciUpperLimit":"0.40"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%","description":"The percentage of participants achieving HbA1c levels \\<7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"302"},{"groupId":"OG001","value":"297"},{"groupId":"OG002","value":"312"},{"groupId":"OG003","value":"176"}]}],"classes":[{"title":"<7.0% at 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"60.9"},{"groupId":"OG001","value":"55.2"},{"groupId":"OG002","value":"37.8"},{"groupId":"OG003","value":"21.0"}]}]},{"title":"<7.0% at 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"57.6"},{"groupId":"OG001","value":"48.8"},{"groupId":"OG002","value":"33.0"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"<7.0% at 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"54.3"},{"groupId":"OG001","value":"44.8"},{"groupId":"OG002","value":"31.1"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"≤6.5% at 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"46.7"},{"groupId":"OG001","value":"31.0"},{"groupId":"OG002","value":"21.8"},{"groupId":"OG003","value":"12.5"}]}]},{"title":"≤6.5% at 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"41.7"},{"groupId":"OG001","value":"29.0"},{"groupId":"OG002","value":"19.2"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"≤6.5% at 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"39.1"},{"groupId":"OG001","value":"24.2"},{"groupId":"OG002","value":"14.1"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"11.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.8","ciUpperLimit":"18.8"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"8.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.2","ciUpperLimit":"14.3"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.8","ciUpperLimit":"4.8"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.7","ciUpperLimit":"5.9"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.8","ciUpperLimit":"3.9"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 104 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.4","ciUpperLimit":"5.0"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c \\<7.0% at 104 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.6","ciUpperLimit":"3.3"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c ≤6.5% at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"11.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.5","ciUpperLimit":"20.4"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c ≤6.5% at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"5.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.8","ciUpperLimit":"8.8"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"Comparison of HbA1c ≤6.5 at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.3","ciUpperLimit":"4.1"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c ≤6.5% at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.9","ciUpperLimit":"6.8"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c ≤6.5% at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.5","ciUpperLimit":"3.5"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c ≤6.5% at 104 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"5.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.4","ciUpperLimit":"7.9"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Comparison of HbA1c ≤6.5% at 104 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.5","ciUpperLimit":"3.7"}]},{"type":"SECONDARY","title":"Incidence of Hypoglycemic Episodes","description":"Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter \\[mmol/L\\]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26 and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"Severe HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Severe HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Documented Symptomatic HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"2"}]}]},{"title":"Documented Symptomatic HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Asymptomatic HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Asymptomatic HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Nocturnal HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}]},{"title":"Nocturnal HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Probable HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}]},{"title":"Probable HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}]},{"type":"SECONDARY","title":"Rate of Hypoglycemic Episodes","description":"Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter \\[mmol/L\\]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"episodes per participant per year","timeFrame":"Baseline through 26 and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"Severe HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.0"},{"groupId":"OG001","value":"0.0","spread":"0.0"},{"groupId":"OG002","value":"0.0","spread":"0.0"},{"groupId":"OG003","value":"0.0","spread":"0.0"}]}]},{"title":"Severe HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.0"},{"groupId":"OG001","value":"0.0","spread":"0.0"},{"groupId":"OG002","value":"0.0","spread":"0.0"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Documented Symptomatic HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"1.5"},{"groupId":"OG001","value":"0.1","spread":"0.9"},{"groupId":"OG002","value":"0.1","spread":"0.7"},{"groupId":"OG003","value":"0.1","spread":"0.9"}]}]},{"title":"Documented Symptomatic HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.9"},{"groupId":"OG001","value":"0.2","spread":"1.9"},{"groupId":"OG002","value":"0.2","spread":"1.4"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Asymptomatic HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.8"},{"groupId":"OG001","value":"0.1","spread":"0.5"},{"groupId":"OG002","value":"0.0","spread":"0.0"},{"groupId":"OG003","value":"0.0","spread":"0.0"}]}]},{"title":"Asymptomatic HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.4"},{"groupId":"OG001","value":"0.0","spread":"0.2"},{"groupId":"OG002","value":"0.0","spread":"0.1"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Nocturnal HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.9"},{"groupId":"OG001","value":"0.1","spread":"0.6"},{"groupId":"OG002","value":"0.0","spread":"0.4"},{"groupId":"OG003","value":"0.0","spread":"0.0"}]}]},{"title":"Nocturnal HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.5"},{"groupId":"OG001","value":"0.0","spread":"0.2"},{"groupId":"OG002","value":"0.1","spread":"0.5"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Probable Symptomatic HE, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.4"},{"groupId":"OG001","value":"0.0","spread":"0.0"},{"groupId":"OG002","value":"0.0","spread":"0.2"},{"groupId":"OG003","value":"0.0","spread":"0.0"}]}]},{"title":"Probable Symptomatic HE, 104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.1"},{"groupId":"OG001","value":"0.0","spread":"0.0"},{"groupId":"OG002","value":"0.0","spread":"0.1"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}]},{"type":"SECONDARY","title":"Beta Cell Function and Insulin Sensitivity (HOMA2)","description":"The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point and who had evaluable HOMA2 data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"HOMA2-%","timeFrame":"Baseline, 26, 52, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"251"},{"groupId":"OG002","value":"238"},{"groupId":"OG003","value":"115"}]}],"classes":[{"title":"HOMA2-%B, 26 Weeks (n=206, 226, 206, 84)","categories":[{"measurements":[{"groupId":"OG000","value":"32.28","spread":"2.67"},{"groupId":"OG001","value":"26.98","spread":"2.60"},{"groupId":"OG002","value":"10.81","spread":"2.66"},{"groupId":"OG003","value":"1.60","spread":"4.02"}]}]},{"title":"HOMA2-%B, 52 Weeks (n=188, 198, 180)","categories":[{"measurements":[{"groupId":"OG000","value":"33.57","spread":"2.51"},{"groupId":"OG001","value":"22.30","spread":"2.47"},{"groupId":"OG002","value":"6.66","spread":"2.53"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"HOMA2-%B, 104 Weeks (n=148, 154, 134)","categories":[{"measurements":[{"groupId":"OG000","value":"30.89","spread":"3.05"},{"groupId":"OG001","value":"19.11","spread":"3.00"},{"groupId":"OG002","value":"1.47","spread":"3.15"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"HOMA2-%S, 26 Weeks (n=206, 226, 206, 84)","categories":[{"measurements":[{"groupId":"OG000","value":"5.75","spread":"2.34"},{"groupId":"OG001","value":"0.78","spread":"2.28"},{"groupId":"OG002","value":"2.29","spread":"2.33"},{"groupId":"OG003","value":"9.82","spread":"3.50"}]}]},{"title":"HOMA2-%S, 52 Weeks (n=188, 198, 180)","categories":[{"measurements":[{"groupId":"OG000","value":"4.69","spread":"2.35"},{"groupId":"OG001","value":"2.28","spread":"2.32"},{"groupId":"OG002","value":"4.25","spread":"2.37"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]},{"title":"HOMA2-%S, 104 Weeks (n=148, 154, 134)","categories":[{"measurements":[{"groupId":"OG000","value":"3.82","spread":"3.00"},{"groupId":"OG001","value":"-0.12","spread":"2.95"},{"groupId":"OG002","value":"5.61","spread":"3.11"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for participants who received Placebo at this time point."}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-emergent Adverse Events at 26 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"185"},{"groupId":"OG003","value":"111"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-emergent Adverse Events at 52 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"All randomized participants in the LY2189265 and active comparator (Sitagliptin) arms.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 52 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"304"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"302"},{"groupId":"OG005","value":"25"},{"groupId":"OG006","value":"24"},{"groupId":"OG007","value":"315"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"233"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"231"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"219"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-emergent Adverse Events at 104 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), 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weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"}]}],"classes":[{"title":"Alkaline Phosphate, High (n=276, 258, 281)","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"20"}]}]},{"title":"ALT/SGPT, High (n=232, 237, 244)","categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"39"}]}]},{"title":"Amylase Pancreatic, High (n=283, 277, 295)","categories":[{"measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"61"}]}]},{"title":"Amylase Total, High (n=266, 265, 277)","categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"43"}]}]},{"title":"AST/SGOT, High (n=273, 269, 284)","categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"36"}]}]},{"title":"Basophils, High (n=276, 268, 288)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Basophils, Low (n=277, 268, 288)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Bilirubin Direct, High (n=295, 291, 307)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"}]}]},{"title":"Bilirubin Total, High (n=295, 290, 305)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"}]}]},{"title":"Calcitonin, High (n=233, 239, 235)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}]},{"title":"Chloride, High (n=299, 293, 310)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}]},{"title":"Chloride, Low (n=299, 293, 308)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"}]}]},{"title":"CPK, High (n=273, 262, 276)","categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"54"}]}]},{"title":"Creatinine, High (n=294, 285, 303)","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"9"}]}]},{"title":"Creatinine Clearance, High (n=164, 186, 180)","categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"34"}]}]},{"title":"Creatinine Clearance, Low (n=292, 278, 303)","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"20"}]}]},{"title":"Eosinophils, High (n=265, 265, 284)","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"14"}]}]},{"title":"Eosinophils, Low (n=277, 268, 288)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Erythrocyte Count, High (n=283, 276, 292)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}]},{"title":"Erythrocyte Count, Low (n=278, 272, 285)","categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"19"}]}]},{"title":"GGT, High (n=234, 240, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"45"}]}]},{"title":"Hematocrit, High (n=280, 274, 290)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"}]}]},{"title":"Hematocrit, Low (n=262, 251, 269)","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"29"}]}]},{"title":"Hemoglobin, High (n=282, 275, 294)","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]},{"title":"Hemoglobin, Low (n=265, 253, 269)","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"25"}]}]},{"title":"Leukocyte Count, High (n=277, 270, 292)","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"8"}]}]},{"title":"Leukocyte Count, Low (n=277, 267, 284)","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"14"}]}]},{"title":"Lipase, High (n=255, 248, 269)","categories":[{"measurements":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"132"},{"groupId":"OG002","value":"126"}]}]},{"title":"Lymphocytes, High (n=257, 262, 279)","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"21"}]}]},{"title":"Lymphocytes, Low (n=273, 266, 281)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"12"}]}]},{"title":"MCHC, High (n=281, 274, 291)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"MCHC, Low (n=280, 272, 290)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"5"}]}]},{"title":"MCV, High (n=267, 256, 273)","categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"25"}]}]},{"title":"MCV, Low (n=270, 261, 286)","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}]},{"title":"Monocytes, High (n=274, 267, 284)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"11"}]}]},{"title":"Monocytes, Low (n=271, 264, 283)","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"17"}]}]},{"title":"Neutrophils, High (n=272, 263, 286)","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"13"}]}]},{"title":"Neutrophils, Low (n=271, 260, 280)","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"10"}]}]},{"title":"Platelet Count, High (n=273, 268, 287)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"}]}]},{"title":"Platelet Count, Low (n=270, 260, 275)","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"}]}]},{"title":"Potassium, High (n=297, 291, 307)","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"8"}]}]},{"title":"Potassium, Low (n=298, 293, 308)","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"5"}]}]},{"title":"Sodium, High (n=291, 291, 307)","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"6"}]}]},{"title":"Sodium, Low (n=298, 292, 305)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"}]}]},{"title":"Urea Nitrogen, High (n=287, 282, 305)","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"29"}]}]},{"title":"UMCR, High (n=223, 212, 239)","categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"30"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-emergent Abnormal Lipid Tests","description":"The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol \\[HDL-C\\], low density lipoprotein cholesterol \\[LDL-C\\], and triglycerides \\[TG\\]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26 and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"Cholesterol, High, 26 Weeks (n=144, 158, 139, 58)","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"8"}]}]},{"title":"Cholesterol, High, 104 Weeks (n=151, 164, 146)","categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"HDL-C, High, 26 Weeks (n=197, 201, 189, 78)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"HDL-C, Low, 26 Weeks (n=127, 137, 129, 52)","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"1"}]}]},{"title":"HDL-C, High, 104 Weeks (n=206, 212, 199)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"HDL-C, Low, 104 Weeks (n=134, 143, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"LDL-C, High, 26 Weeks (n=155, 163, 150, 61)","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"7"}]}]},{"title":"LDL-C, High, 104 Weeks (n=163, 170, 157)","categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"29"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"TG, High, 26 Weeks (n=163, 174, 156, 64)","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"2"}]}]},{"title":"TG, High, 104 Weeks (n=170, 183, 166)","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse Rate at Dose Decision Point","description":"Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.","populationDescription":"All participants randomized before the dose decision point who had evaluable sitting pulse rate data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline up to 27.4 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG008","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"20"},{"groupId":"OG005","value":"22"},{"groupId":"OG006","value":"17"},{"groupId":"OG007","value":"35"},{"groupId":"OG008","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.63","spread":"7.28"},{"groupId":"OG001","value":"3.43","spread":"10.14"},{"groupId":"OG002","value":"2.39","spread":"7.88"},{"groupId":"OG003","value":"3.34","spread":"9.88"},{"groupId":"OG004","value":"-1.63","spread":"8.03"},{"groupId":"OG005","value":"1.91","spread":"6.18"},{"groupId":"OG006","value":"1.05","spread":"9.44"},{"groupId":"OG007","value":"-0.16","spread":"8.07"},{"groupId":"OG008","value":"1.81","spread":"7.90"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Blood Pressure at Dose Decision Point","description":"Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.","populationDescription":"All participants randomized before the dose decision point who had evaluable sitting SBP and DBP data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline up to 27.4 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG008","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"20"},{"groupId":"OG005","value":"22"},{"groupId":"OG006","value":"17"},{"groupId":"OG007","value":"35"},{"groupId":"OG008","value":"33"}]}],"classes":[{"title":"Sitting SBP","categories":[{"measurements":[{"groupId":"OG000","value":"-8.85","spread":"12.92"},{"groupId":"OG001","value":"-4.63","spread":"15.28"},{"groupId":"OG002","value":"-4.77","spread":"11.37"},{"groupId":"OG003","value":"-2.00","spread":"9.94"},{"groupId":"OG004","value":"-6.21","spread":"19.13"},{"groupId":"OG005","value":"0.40","spread":"11.51"},{"groupId":"OG006","value":"1.67","spread":"10.18"},{"groupId":"OG007","value":"-2.16","spread":"10.62"},{"groupId":"OG008","value":"-0.61","spread":"14.75"}]}]},{"title":"Sitting DBP","categories":[{"measurements":[{"groupId":"OG000","value":"-1.21","spread":"7.47"},{"groupId":"OG001","value":"-1.17","spread":"6.32"},{"groupId":"OG002","value":"-1.20","spread":"4.67"},{"groupId":"OG003","value":"-0.08","spread":"8.00"},{"groupId":"OG004","value":"-3.18","spread":"10.13"},{"groupId":"OG005","value":"-0.75","spread":"7.99"},{"groupId":"OG006","value":"1.28","spread":"4.06"},{"groupId":"OG007","value":"-1.11","spread":"6.65"},{"groupId":"OG008","value":"-0.22","spread":"7.94"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse Rate","description":"Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable pulse data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline, 26 weeks, 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"Sitting, 26 Weeks (n=271, 278, 283, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"2.57","spread":"0.47"},{"groupId":"OG001","value":"1.90","spread":"0.47"},{"groupId":"OG002","value":"-0.11","spread":"0.46"},{"groupId":"OG003","value":"-0.22","spread":"0.65"}]}]},{"title":"Sitting, 104 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"2.28","spread":"0.53"},{"groupId":"OG001","value":"2.77","spread":"0.54"},{"groupId":"OG002","value":"-0.78","spread":"0.53"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Standing, 26 Weeks (n=271, 277, 281, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"3.24","spread":"0.52"},{"groupId":"OG001","value":"2.00","spread":"0.52"},{"groupId":"OG002","value":"-0.24","spread":"0.51"},{"groupId":"OG003","value":"-0.17","spread":"0.71"}]}]},{"title":"Standing, 104 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"2.26","spread":"0.63"},{"groupId":"OG001","value":"2.50","spread":"0.64"},{"groupId":"OG002","value":"-1.06","spread":"0.63"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Blood Pressure","description":"Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable SBP and DBP data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 26 weeks, 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"Sitting SBP, 26 Weeks (n=271, 278, 283, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.73","spread":"0.67"},{"groupId":"OG001","value":"-1.40","spread":"0.67"},{"groupId":"OG002","value":"-1.94","spread":"0.66"},{"groupId":"OG003","value":"1.12","spread":"0.92"}]}]},{"title":"Sitting SBP, 104 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.81"},{"groupId":"OG001","value":"1.28","spread":"0.82"},{"groupId":"OG002","value":"0.02","spread":"0.82"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Sitting DBP, 26 Weeks (n=271, 278, 283, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.43","spread":"0.43"},{"groupId":"OG001","value":"-0.20","spread":"0.43"},{"groupId":"OG002","value":"-1.06","spread":"0.42"},{"groupId":"OG003","value":"0.68","spread":"0.58"}]}]},{"title":"Sitting DBP, 104 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"0.38","spread":"0.52"},{"groupId":"OG001","value":"1.40","spread":"0.52"},{"groupId":"OG002","value":"-0.36","spread":"0.52"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Standing SBP, 26 Weeks (n=271, 277, 281, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.53","spread":"0.76"},{"groupId":"OG001","value":"-1.72","spread":"0.76"},{"groupId":"OG002","value":"-2.54","spread":"0.74"},{"groupId":"OG003","value":"0.26","spread":"1.04"}]}]},{"title":"Standing SBP, 104 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.30","spread":"0.92"},{"groupId":"OG001","value":"0.17","spread":"0.93"},{"groupId":"OG002","value":"-1.20","spread":"0.92"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"Standing DBP, 26 Weeks (n=271, 277, 281, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.11","spread":"0.48"},{"groupId":"OG001","value":"0.03","spread":"0.48"},{"groupId":"OG002","value":"-1.36","spread":"0.47"},{"groupId":"OG003","value":"-0.52","spread":"0.66"}]}]},{"title":"Standing DBP, 104 Weeks (n=197, 192, 191)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.23","spread":"0.57"},{"groupId":"OG001","value":"0.36","spread":"0.58"},{"groupId":"OG002","value":"-0.67","spread":"0.58"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval","description":"The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable ECG data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milliseconds (msec)","timeFrame":"Baseline, 26 weeks, 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"177"}]}],"classes":[{"title":"PR Interval, 26 Weeks (n=256, 261, 268, 132)","categories":[{"measurements":[{"groupId":"OG000","value":"2.94","spread":"0.66"},{"groupId":"OG001","value":"1.60","spread":"0.66"},{"groupId":"OG002","value":"0.42","spread":"0.65"},{"groupId":"OG003","value":"2.24","spread":"0.89"}]}]},{"title":"PR Interval, 104 Weeks (n=168, 170, 167)","categories":[{"measurements":[{"groupId":"OG000","value":"4.59","spread":"0.90"},{"groupId":"OG001","value":"3.06","spread":"0.90"},{"groupId":"OG002","value":"3.19","spread":"0.90"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]},{"title":"QTcF Interval, 26 Weeks (n=258, 262, 268, 132)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.86","spread":"0.75"},{"groupId":"OG001","value":"-2.44","spread":"0.75"},{"groupId":"OG002","value":"-1.31","spread":"0.73"},{"groupId":"OG003","value":"1.76","spread":"1.02"}]}]},{"title":"QTcF Interval, 104 Weeks (n=169, 170, 168)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.71","spread":"0.84"},{"groupId":"OG001","value":"-2.49","spread":"0.84"},{"groupId":"OG002","value":"-0.02","spread":"0.83"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"Placebo treatment lasted through 26 weeks. Thus, there are no data for this treatment arm at this time point."}]}]}]},{"type":"SECONDARY","title":"Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)","description":"The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants' quality of life. Items are scored on a 5-point numeric rating scale where 5 = \"always true\" and 1 = \"never true\". Items are summed into 6 scales (physical function \\[11 items\\], self-esteem \\[7 items\\], sexual life \\[4 items\\], public distress \\[5 items\\], work \\[4 items\\], and total score \\[31 items\\]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable IWQoL-Lite data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 52 weeks, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"}]}],"classes":[{"title":"Total Score, Baseline (n=285, 284, 300)","categories":[{"measurements":[{"groupId":"OG000","value":"83.41","spread":"16.031"},{"groupId":"OG001","value":"82.55","spread":"16.952"},{"groupId":"OG002","value":"83.97","spread":"16.514"}]}]},{"title":"Total Score, 52 Weeks (n=237, 252, 247)","categories":[{"measurements":[{"groupId":"OG000","value":"86.92","spread":"14.972"},{"groupId":"OG001","value":"86.31","spread":"14.673"},{"groupId":"OG002","value":"86.25","spread":"15.628"}]}]},{"title":"Total Score, 104 Weeks (n=190, 190, 185)","categories":[{"measurements":[{"groupId":"OG000","value":"88.08","spread":"15.555"},{"groupId":"OG001","value":"87.47","spread":"15.183"},{"groupId":"OG002","value":"86.93","spread":"16.304"}]}]}]},{"type":"SECONDARY","title":"Participant-reported Outcomes, EQ-5D","description":"The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable EQ-5D data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 52 weeks, and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"}]}],"classes":[{"title":"EQ-5D, UK, Baseline (n=285, 281, 300)","categories":[{"measurements":[{"groupId":"OG000","value":"0.80","spread":"0.222"},{"groupId":"OG001","value":"0.82","spread":"0.223"},{"groupId":"OG002","value":"0.84","spread":"0.216"}]}]},{"title":"EQ-5D, UK, 52 Weeks (n=237, 250, 244)","categories":[{"measurements":[{"groupId":"OG000","value":"0.83","spread":"0.211"},{"groupId":"OG001","value":"0.84","spread":"0.208"},{"groupId":"OG002","value":"0.85","spread":"0.210"}]}]},{"title":"EQ-5D, UK, 104 Weeks (n=189, 190, 185)","categories":[{"measurements":[{"groupId":"OG000","value":"0.84","spread":"0.203"},{"groupId":"OG001","value":"0.86","spread":"0.184"},{"groupId":"OG002","value":"0.86","spread":"0.198"}]}]},{"title":"VAS, Baseline (n=285, 284, 301)","categories":[{"measurements":[{"groupId":"OG000","value":"75.57","spread":"15.798"},{"groupId":"OG001","value":"75.35","spread":"16.001"},{"groupId":"OG002","value":"76.85","spread":"15.363"}]}]},{"title":"VAS, 52 Weeks (n=238, 251, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"78.93","spread":"13.352"},{"groupId":"OG001","value":"78.22","spread":"13.839"},{"groupId":"OG002","value":"78.79","spread":"14.567"}]}]},{"title":"VAS, 104 Weeks (n=189, 190, 185)","categories":[{"measurements":[{"groupId":"OG000","value":"79.66","spread":"13.820"},{"groupId":"OG001","value":"78.52","spread":"14.114"},{"groupId":"OG002","value":"81.34","spread":"13.708"}]}]}]},{"type":"SECONDARY","title":"Resource Utilization","description":"The number of visits to the emergency room (ER) is summarized cumulatively.","populationDescription":"All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Baseline through 52 and 104 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG002","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"302"},{"groupId":"OG002","value":"315"}]}],"classes":[{"title":"52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"NA","comment":"Data were not summarized cumulatively for this outcome measure."},{"groupId":"OG001","value":"NA","comment":"Data were not summarized cumulatively for this outcome measure."},{"groupId":"OG002","value":"NA","comment":"Data were not summarized cumulatively for this outcome measure."}]}]},{"title":"104 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"NA","comment":"Data were not summarized cumulatively for this outcome measure."},{"groupId":"OG001","value":"NA","comment":"Data were not summarized cumulatively for this outcome measure."},{"groupId":"OG002","value":"NA","comment":"Data were not summarized cumulatively for this outcome measure."}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve","description":"Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.","populationDescription":"Randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) who had blood samples collected for PK assessments.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms times hours per milliliter","timeFrame":"Baseline through 52 weeks","groups":[{"id":"OG000","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG001","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13378","spread":"6100"},{"groupId":"OG001","value":"7246","spread":"3304"}]}]}]},{"type":"SECONDARY","title":"Antibodies to LY2189265","description":"The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.","populationDescription":"All randomized participants in the LY2189265 arms who had evaluable ADA data. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 104 weeks","groups":[{"id":"OG000","title":"LY2189265","description":"LY2189265 (Dulaglutide): 3.0, 2.0, 1.5, 1.0, 0.75, 0.5, or 0.25 milligrams (mg), subcutaneous (SC), once weekly for up to 104 weeks.\n\nPlacebo: tablet, administered orally, once daily for up to 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"698"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Adjudicated Pancreatitis at 104 Weeks","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"All randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 104 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG008","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG009","title":"Placebo/Sitagliptin (26 Weeks Through 104 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"304"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"302"},{"groupId":"OG005","value":"25"},{"groupId":"OG006","value":"24"},{"groupId":"OG007","value":"315"},{"groupId":"OG008","value":"177"},{"groupId":"OG009","value":"177"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks","description":"Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"All randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 104 weeks","groups":[{"id":"OG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"},{"id":"OG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"},{"id":"OG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"},{"id":"OG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"},{"id":"OG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG008","title":"Placebo/Sitagliptin (Baseline Through 26 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"},{"id":"OG009","title":"Placebo/Sitagliptin (26 Weeks Through 104 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"304"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"302"},{"groupId":"OG005","value":"25"},{"groupId":"OG006","value":"24"},{"groupId":"OG007","value":"315"},{"groupId":"OG008","value":"177"},{"groupId":"OG009","value":"177"}]}],"classes":[{"title":"Participants With Any CV Event","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"3"}]}]},{"title":"Participants With a Fatal CV Event","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"}]}]},{"title":"Participants With a Non-fatal CV Event","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"2"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"3.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)","seriousNumAffected":1,"seriousNumAtRisk":15,"otherNumAffected":9,"otherNumAtRisk":15},{"id":"EG001","title":"2.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)","seriousNumAffected":1,"seriousNumAtRisk":30,"otherNumAffected":20,"otherNumAtRisk":30},{"id":"EG002","title":"1.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks","seriousNumAffected":36,"seriousNumAtRisk":304,"otherNumAffected":252,"otherNumAtRisk":304},{"id":"EG003","title":"1.0 mg LY2189265","description":"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":8,"otherNumAtRisk":10},{"id":"EG004","title":"0.75 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally, for 104 weeks","seriousNumAffected":23,"seriousNumAtRisk":302,"otherNumAffected":255,"otherNumAtRisk":302},{"id":"EG005","title":"0.5 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)","seriousNumAffected":1,"seriousNumAtRisk":25,"otherNumAffected":15,"otherNumAtRisk":25},{"id":"EG006","title":"0.25 mg LY2189265","description":"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)\n\nPlacebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)","seriousNumAffected":0,"seriousNumAtRisk":24,"otherNumAffected":10,"otherNumAtRisk":24},{"id":"EG007","title":"Sitagliptin","description":"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks\n\nPlacebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks","seriousNumAffected":32,"seriousNumAtRisk":315,"otherNumAffected":239,"otherNumAtRisk":315},{"id":"EG008","title":"Placebo/Sitagliptin (Baseline Through 104 Weeks)","description":"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks\n\nPlacebo: tablet, administered orally, once daily for 26 weeks\n\nSitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily, for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks","seriousNumAffected":17,"seriousNumAtRisk":177,"otherNumAffected":138,"otherNumAtRisk":177}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Lymphadenitis","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":1,"numAffected":1,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":1,"numAffected":1,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":1,"numAffected":1,"numAtRisk":177}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Cardio-respiratory arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Event resulted in death","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":1,"numAffected":1,"numAtRisk":177}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Coronary artery stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Mitral valve incompetence","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":0,"numAffected":0,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":1,"numAffected":1,"numAtRisk":315},{"groupId":"EG008","numEvents":2,"numAffected":2,"numAtRisk":177}]},{"term":"Myocardial ischaemia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":304},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":302},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":25},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":24},{"groupId":"EG007","numEvents":1,"numAffected":1,"numAtRisk":315},{"groupId":"EG008","numEvents":0,"numAffected":0,"numAtRisk":177}]},{"term":"Prinzmetal angina","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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