{"protocolSection":{"identificationModule":{"nctId":"NCT01075282","orgStudyIdInfo":{"id":"11374"},"secondaryIdInfos":[{"id":"H9X-MC-GBDB","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)","officialTitle":"A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride","acronym":"AWARD-2"},"statusModule":{"statusVerifiedDate":"2015-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-02"},"primaryCompletionDateStruct":{"date":"2012-05","type":"ACTUAL"},"completionDateStruct":{"date":"2012-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-02-23","studyFirstSubmitQcDate":"2010-02-23","studyFirstPostDateStruct":{"date":"2010-02-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-03","resultsFirstSubmitQcDate":"2015-01-15","resultsFirstPostDateStruct":{"date":"2015-01-16","type":"ESTIMATED"},"dispFirstSubmitDate":"2012-09-18","dispFirstSubmitQcDate":"2012-09-18","dispFirstPostDateStruct":{"date":"2012-09-25","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-01-15","lastUpdatePostDateStruct":{"date":"2015-01-16","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.","detailedDescription":"Rescue therapy refers to 1 of 2 types of additional therapy, each given for a different reason: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":810,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY2189265 1.5 mg","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks","interventionNames":["Drug: LY2189265","Drug: Metformin","Drug: Glimepiride"]},{"label":"LY2189265 0.75 mg","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks","interventionNames":["Drug: LY2189265","Drug: Metformin","Drug: Glimepiride"]},{"label":"Insulin Glargine","type":"ACTIVE_COMPARATOR","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks","interventionNames":["Drug: Insulin Glargine","Drug: Metformin","Drug: Glimepiride"]}],"interventions":[{"type":"DRUG","name":"Insulin Glargine","armGroupLabels":["Insulin Glargine"]},{"type":"DRUG","name":"LY2189265","armGroupLabels":["LY2189265 0.75 mg","LY2189265 1.5 mg"],"otherNames":["Dulaglutide"]},{"type":"DRUG","name":"Metformin","armGroupLabels":["Insulin Glargine","LY2189265 0.75 mg","LY2189265 1.5 mg"]},{"type":"DRUG","name":"Glimepiride","armGroupLabels":["Insulin Glargine","LY2189265 0.75 mg","LY2189265 1.5 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)","description":"Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.","timeFrame":"Baseline, 52 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)","description":"Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.","timeFrame":"Baseline, 26 weeks, and 78 weeks"},{"measure":"Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks","description":"Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.","timeFrame":"26, 52, and 78 weeks"},{"measure":"Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks","description":"Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.","timeFrame":"26, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles","description":"The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) 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 78 weeks"},{"measure":"Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)","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 HOMA-2S 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, 52, and 78 weeks"},{"measure":"Change From Baseline to 52 and 78 Weeks in Glucagon Concentration","description":"Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks for Body Weight","description":"Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index","description":"Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. 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 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension","description":"The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm 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). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living","description":"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire \\[APPADL\\]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = \"not at all difficult\" and 1 = \"unable to do\". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception","description":"The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey","description":"The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 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 one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"26, 52, and 78 weeks"},{"measure":"Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of 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 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. 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, 52, and 78 weeks"},{"measure":"Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of 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 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. 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, 52, and 78 weeks"},{"measure":"Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks","description":"Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.","timeFrame":"26, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured.","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. 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, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin","timeFrame":"Baseline, 26, 52, and 78 weeks"},{"measure":"Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks","description":"Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new 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 at 26, 52, and 78 weeks. 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, 52, and 78 weeks"},{"measure":"Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate","description":"Sitting pulse rate was 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, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure","description":"Sitting systolic blood pressure (SBP) and sitting 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, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate","description":"Electrocardiogram (ECG) heart rate was 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, 52, and 78 weeks"},{"measure":"Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval 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, 52, and 78 weeks"},{"measure":"Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)","description":"LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.","timeFrame":"Baseline, 26, 52, 78, and 83 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)\n\n  1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication\n  2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications\n* Accept treatment with metformin and glimepiride throughout the study, as per protocol\n* Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.\n* Stable weight for 3 months prior to screening\n* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\\^2)\n* Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug\n\nExclusion Criteria:\n\n* Type 1 Diabetes\n* HbA1c equal to or less than 6.5 at randomization\n* Chronic insulin use\n* Taking drugs to promote weight loss by prescription or over the counter\n* Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled\n* History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening\n* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility\n* Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit\n* Acute or chronic pancreatitis of any form\n* Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)\n* History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer\n* A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening\n* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis\n* History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years\n* Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing\n* Organ transplant except cornea\n* Have enrolled in another clinical trial within the last 30 days\n* Have previously signed an informed consent or participated in a LY2189265 study\n* Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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_DIRECTOR"}],"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":"Buenos Aires","zip":"C1425AGC","country":"Argentina","geoPoint":{"lat":-34.61315,"lon":-58.37723}},{"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":"Caba","zip":"C1417EYG","country":"Argentina"},{"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":"Córdoba","zip":"5006","country":"Argentina","geoPoint":{"lat":-31.40648,"lon":-64.18853}},{"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":"Mendoza","zip":"5500","country":"Argentina","geoPoint":{"lat":-32.88946,"lon":-68.84582}},{"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":"Wollongong","state":"New South Wales","zip":"2500","country":"Australia","geoPoint":{"lat":-34.424,"lon":150.89345}},{"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":"Brisbane","state":"Queensland","zip":"4029","country":"Australia","geoPoint":{"lat":-27.46794,"lon":153.02809}},{"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":"Keswick","state":"South Australia","zip":"5035","country":"Australia","geoPoint":{"lat":-34.94178,"lon":138.57459}},{"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":"East Ringwood","state":"Victoria","zip":"3135","country":"Australia"},{"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":"Heidelberg","state":"Victoria","zip":"3081","country":"Australia","geoPoint":{"lat":-37.75,"lon":145.06667}},{"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":"Gribomont","zip":"6887","country":"Belgium","geoPoint":{"lat":49.82166,"lon":5.3243}},{"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":"Halen","zip":"3545","country":"Belgium","geoPoint":{"lat":50.94837,"lon":5.11096}},{"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":"Leuven","zip":"3000","country":"Belgium","geoPoint":{"lat":50.87959,"lon":4.70093}},{"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":"Joinville","zip":"89201-260","country":"Brazil","geoPoint":{"lat":-26.30444,"lon":-48.84556}},{"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":"São Paulo","zip":"05403-900","country":"Brazil","geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"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":"Edmonton","state":"Alberta","zip":"T5J 3N4","country":"Canada","geoPoint":{"lat":53.55014,"lon":-113.46871}},{"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":"Coquitlam","state":"British Columbia","zip":"V3K 3P4","country":"Canada","geoPoint":{"lat":49.2846,"lon":-122.78217}},{"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":"R3E 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":"St. John's","state":"Newfoundland and Labrador","zip":"A1E 2C2","country":"Canada","geoPoint":{"lat":47.56494,"lon":-52.70931}},{"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":"Markham","state":"Ontario","zip":"L6B 0P9","country":"Canada","geoPoint":{"lat":43.86682,"lon":-79.2663}},{"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":"Mississauga","state":"Ontario","zip":"L5M 2V8","country":"Canada","geoPoint":{"lat":43.5789,"lon":-79.6583}},{"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":"Montreal","state":"Quebec","zip":"H2W 1R7","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"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":"Osijek","zip":"31000","country":"Croatia","geoPoint":{"lat":45.55066,"lon":18.6942}},{"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":"Slavonski Brod","zip":"35 000","country":"Croatia","geoPoint":{"lat":45.16158,"lon":18.0163}},{"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":"Zagreb","zip":"10000","country":"Croatia","geoPoint":{"lat":45.81444,"lon":15.97798}},{"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":"Holešov","zip":"769 01","country":"Czechia","geoPoint":{"lat":49.33331,"lon":17.57832}},{"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":"Prague","zip":"140 59","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"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":"Dijon","zip":"21079","country":"France","geoPoint":{"lat":47.31344,"lon":5.01391}},{"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":"Nantes","zip":"44093","country":"France","geoPoint":{"lat":47.21725,"lon":-1.55336}},{"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":"Pessac","zip":"33604","country":"France","geoPoint":{"lat":44.80565,"lon":-0.6324}},{"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":"Tours","zip":"37044","country":"France","geoPoint":{"lat":47.39484,"lon":0.70398}},{"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","zip":"11527","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"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":"Budapest","zip":"1036","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"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":"Makó","zip":"6900","country":"Hungary","geoPoint":{"lat":46.21667,"lon":20.48333}},{"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":"Mosonmagyaróvár","zip":"9200","country":"Hungary","geoPoint":{"lat":47.86789,"lon":17.26994}},{"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":"Székesfehérvár","zip":"8000","country":"Hungary","geoPoint":{"lat":47.18995,"lon":18.41034}},{"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":"Aligarh","zip":"202002","country":"India","geoPoint":{"lat":27.88145,"lon":78.07464}},{"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":"560003","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":"Chennai","zip":"600029","country":"India","geoPoint":{"lat":13.08784,"lon":80.27847}},{"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":"Indore","zip":"452002","country":"India","geoPoint":{"lat":22.71792,"lon":75.8333}},{"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":"Jaipur","zip":"302001","country":"India","geoPoint":{"lat":26.91962,"lon":75.78781}},{"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":"Mumbai","zip":"400053","country":"India","geoPoint":{"lat":19.07283,"lon":72.88261}},{"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":"Patna","zip":"800 020","country":"India","geoPoint":{"lat":25.59408,"lon":85.13563}},{"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":"Florence","zip":"50141","country":"Italy","geoPoint":{"lat":43.77925,"lon":11.24626}},{"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":"Milan","zip":"20132","country":"Italy","geoPoint":{"lat":42.78235,"lon":12.59836}},{"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":"Coatzacoalcos","zip":"96400","country":"Mexico","geoPoint":{"lat":18.14905,"lon":-94.4447}},{"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":"Cuernavaca","zip":"62250","country":"Mexico","geoPoint":{"lat":18.9261,"lon":-99.23075}},{"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":"44656","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":"64570","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":"Bialystok","zip":"15-404","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"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":"Bydogoszcz","zip":"85-094","country":"Poland"},{"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":"Krakow","zip":"31-261","country":"Poland","geoPoint":{"lat":50.06143,"lon":19.93658}},{"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":"71-455","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":"Warsaw","zip":"02-507","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"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":"50-127","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":"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":"Bucharest","zip":"020045","country":"Romania","geoPoint":{"lat":44.43225,"lon":26.10626}},{"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":"Galati","zip":"800587","country":"Romania","geoPoint":{"lat":45.43687,"lon":28.05028}},{"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":"Oradea","zip":"410025","country":"Romania","geoPoint":{"lat":47.0458,"lon":21.91833}},{"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":"Košice","zip":"04001","country":"Slovakia","geoPoint":{"lat":48.71441,"lon":21.25802}},{"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":"Bucheon-si","zip":"420-717","country":"South Korea","geoPoint":{"lat":37.49889,"lon":126.78306}},{"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":"Ilsan","zip":"411706","country":"South Korea","geoPoint":{"lat":35.5,"lon":129.43333}},{"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":"Pusan","zip":"614-735","country":"South Korea","geoPoint":{"lat":36.3809,"lon":128.3681}},{"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":"Alicante","zip":"03114","country":"Spain","geoPoint":{"lat":38.34517,"lon":-0.48149}},{"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":"Ávila","zip":"05004","country":"Spain","geoPoint":{"lat":40.65724,"lon":-4.69951}},{"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":"Palencia","zip":"34005","country":"Spain","geoPoint":{"lat":42.00955,"lon":-4.52406}},{"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":"Requena","zip":"46340","country":"Spain","geoPoint":{"lat":39.48834,"lon":-1.10044}},{"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":"Gothenburg","zip":"41345","country":"Sweden","geoPoint":{"lat":57.70716,"lon":11.96679}},{"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":"Helsingborg","zip":"25187","country":"Sweden","geoPoint":{"lat":56.04673,"lon":12.69437}},{"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":"Lund","zip":"22185","country":"Sweden","geoPoint":{"lat":55.70584,"lon":13.19321}},{"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":"Stockholm","zip":"11157","country":"Sweden","geoPoint":{"lat":59.32938,"lon":18.06871}},{"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":"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":"11031","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":"Taoyuan","zip":"333","country":"Taiwan","geoPoint":{"lat":23.60361,"lon":120.59056}},{"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":"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":"26089386","type":"DERIVED","citation":"Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"FG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"FG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"273"},{"groupId":"FG001","numSubjects":"272"},{"groupId":"FG002","comment":"Of 265 participants randomized to Insulin Glargine, 3 chose not to take study drug.","numSubjects":"265"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"273"},{"groupId":"FG001","numSubjects":"272"},{"groupId":"FG002","numSubjects":"262"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"242"},{"groupId":"FG001","numSubjects":"243"},{"groupId":"FG002","numSubjects":"238"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"27"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"Adverse 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The confidence interval is not adjusted for multiplicity.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"-0.13"},{"groupIds":["OG001","OG002"],"groupDescription":"Superiority analysis.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.378","pValueComment":"Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and 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":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.21","ciUpperLimit":"0.15"}]},{"type":"SECONDARY","title":"Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks","description":"Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"participants","timeFrame":"26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks (n=263, 266, 258)","categories":[{"measurements":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"84"}]}]},{"title":"52 weeks (n=263, 267, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"80"}]}]},{"title":"78 weeks (n=263, 267, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"91"},{"groupId":"OG002","value":"79"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.98","ciUpperLimit":"7.11"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.41","ciUpperLimit":"3.24"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.45","ciUpperLimit":"5.75"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.098","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.94","ciUpperLimit":"2.15"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.85","ciUpperLimit":"4.14"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.334","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.82","ciUpperLimit":"1.82"}]},{"type":"SECONDARY","title":"Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks","description":"Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"participants","timeFrame":"26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks (n=263, 266, 258)","categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"40"}]}]},{"title":"52 weeks (n=263, 267, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"35"}]}]},{"title":"78 weeks (n=263, 267, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"43"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.70","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.90","ciUpperLimit":"7.63"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.57","ciUpperLimit":"4.11"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.81","ciUpperLimit":"4.85"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.26","ciUpperLimit":"3.39"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"Regression, Logistic","statisticalComment":"Treatment comparison at 78 weeks.","paramType":"Odds Ratio (OR)","paramValue":"2.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.44","ciUpperLimit":"3.57"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.073","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.96","ciUpperLimit":"2.42"}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles","description":"The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) 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":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMBG data. Only pre-rescue measurements were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"242"},{"groupId":"OG002","value":"228"}]}],"classes":[{"title":"26 weeks (n=199, 204, 190)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.79","spread":"0.10"},{"groupId":"OG001","value":"-1.46","spread":"0.10"},{"groupId":"OG002","value":"-1.58","spread":"0.10"}]}]},{"title":"52 weeks (n=180, 185, 176)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.69","spread":"0.11"},{"groupId":"OG001","value":"-1.32","spread":"0.11"},{"groupId":"OG002","value":"-1.44","spread":"0.11"}]}]},{"title":"78 weeks (n=172, 164, 168)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.55","spread":"0.13"},{"groupId":"OG001","value":"-1.15","spread":"0.12"},{"groupId":"OG002","value":"-1.47","spread":"0.13"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.109","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.335","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.091","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.400","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.641","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.055","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)","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 HOMA-2S 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":"Participants who were randomized and received at least one dose of LY2189265 with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HOMA2","timeFrame":"Baseline, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"230"}]}],"classes":[{"title":"HOMA2-%B, 52 weeks (n=175, 181)","categories":[{"measurements":[{"groupId":"OG000","value":"29.95","spread":"4.61"},{"groupId":"OG001","value":"24.60","spread":"4.51"}]}]},{"title":"HOMA2-%B, 78 weeks (n=167, 165)","categories":[{"measurements":[{"groupId":"OG000","value":"28.54","spread":"4.78"},{"groupId":"OG001","value":"15.66","spread":"4.75"}]}]},{"title":"HOMA2-%S, 52 weeks (n=175,181)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.89","spread":"1.21"},{"groupId":"OG001","value":"-2.66","spread":"1.19"}]}]},{"title":"HOMA2-%S, 78 weeks (n=167, 165)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.64","spread":"1.23"},{"groupId":"OG001","value":"-3.62","spread":"1.23"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 52 and 78 Weeks in Glucagon Concentration","description":"Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable glucagon data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"picomoles per liter (pmol/L)","timeFrame":"Baseline, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"235"},{"groupId":"OG001","value":"235"},{"groupId":"OG002","value":"232"}]}],"classes":[{"title":"52 weeks (n=232, 231, 228)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.91","spread":"0.47"},{"groupId":"OG001","value":"-3.31","spread":"0.47"},{"groupId":"OG002","value":"-3.85","spread":"0.47"}]}]},{"title":"78 weeks (n=235, 235, 232)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.57","spread":"0.47"},{"groupId":"OG001","value":"-3.37","spread":"0.47"},{"groupId":"OG002","value":"-3.65","spread":"0.47"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks for Body Weight","description":"Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"kilogram (kg)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"270"},{"groupId":"OG002","value":"259"}]}],"classes":[{"title":"26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.82","spread":"0.20"},{"groupId":"OG001","value":"-1.47","spread":"0.20"},{"groupId":"OG002","value":"1.01","spread":"0.20"}]}]},{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.87","spread":"0.24"},{"groupId":"OG001","value":"-1.33","spread":"0.24"},{"groupId":"OG002","value":"1.44","spread":"0.24"}]}]},{"title":"78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.96","spread":"0.26"},{"groupId":"OG001","value":"-1.54","spread":"0.26"},{"groupId":"OG002","value":"1.28","spread":"0.26"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.33","ciUpperLimit":"3.33"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.99","ciUpperLimit":"2.99"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"3.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.71","ciUpperLimit":"3.90"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 52 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.17","ciUpperLimit":"3.36"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"3.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.59","ciUpperLimit":"3.89"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 78 weeks.","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"2.82","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.17","ciUpperLimit":"3.46"}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index","description":"Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. 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":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms per square meter (kg/m^2)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks (n=257, 261, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.64","spread":"0.07"},{"groupId":"OG001","value":"-0.50","spread":"0.07"},{"groupId":"OG002","value":"0.44","spread":"0.07"}]}]},{"title":"52 weeks (n=250, 252, 238)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.64","spread":"0.08"},{"groupId":"OG001","value":"-0.39","spread":"0.08"},{"groupId":"OG002","value":"0.62","spread":"0.08"}]}]},{"title":"78 weeks (n=246, 244, 238)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.64","spread":"0.09"},{"groupId":"OG001","value":"-0.39","spread":"0.09"},{"groupId":"OG002","value":"0.59","spread":"0.10"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension","description":"The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm 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). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"units on a scale","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"EQ-5D UK, 26 weeks (n=257, 254, 249)","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.01"},{"groupId":"OG001","value":"0.00","spread":"0.01"},{"groupId":"OG002","value":"-0.01","spread":"0.01"}]}]},{"title":"EQ-5D UK, 52 weeks (n=259, 260, 253)","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.01"},{"groupId":"OG001","value":"0.00","spread":"0.01"},{"groupId":"OG002","value":"-0.04","spread":"0.01"}]}]},{"title":"EQ-5D UK, 78 weeks (n=259, 260, 253)","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.01"},{"groupId":"OG001","value":"0.00","spread":"0.01"},{"groupId":"OG002","value":"0.00","spread":"0.01"}]}]},{"title":"VAS, 26 weeks (n=253, 252, 243)","categories":[{"measurements":[{"groupId":"OG000","value":"3.3","spread":"0.83"},{"groupId":"OG001","value":"3.4","spread":"0.84"},{"groupId":"OG002","value":"0.8","spread":"0.86"}]}]},{"title":"VAS, 52 weeks (n=260, 258, 252)","categories":[{"measurements":[{"groupId":"OG000","value":"3.2","spread":"0.85"},{"groupId":"OG001","value":"2.3","spread":"0.85"},{"groupId":"OG002","value":"1.1","spread":"0.88"}]}]},{"title":"VAS, 78 weeks (n=260, 258, 252)","categories":[{"measurements":[{"groupId":"OG000","value":"3.8","spread":"0.85"},{"groupId":"OG001","value":"3.2","spread":"0.85"},{"groupId":"OG002","value":"2.2","spread":"0.89"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living","description":"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire \\[APPADL\\]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = \"not at all difficult\" and 1 = \"unable to do\". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"units on a scale","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"260"}]}],"classes":[{"title":"26 weeks (n=256, 256, 248)","categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"0.30"},{"groupId":"OG001","value":"0.1","spread":"0.30"},{"groupId":"OG002","value":"-0.3","spread":"0.30"}]}]},{"title":"52 weeks (n=260, 261, 249)","categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"0.31"},{"groupId":"OG001","value":"0.4","spread":"0.31"},{"groupId":"OG002","value":"-0.6","spread":"0.32"}]}]},{"title":"78 weeks (n=260, 261, 249)","categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"0.31"},{"groupId":"OG001","value":"0.3","spread":"0.31"},{"groupId":"OG002","value":"-0.3","spread":"0.32"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception","description":"The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"units on a scale","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks (n=258, 258, 251)","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.16"},{"groupId":"OG001","value":"0.2","spread":"0.16"},{"groupId":"OG002","value":"-0.1","spread":"0.16"}]}]},{"title":"52 weeks (n=260, 261, 252)","categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.16"},{"groupId":"OG001","value":"0.2","spread":"0.16"},{"groupId":"OG002","value":"0.1","spread":"0.16"}]}]},{"title":"78 weeks (n=260, 261, 252)","categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.16"},{"groupId":"OG001","value":"0.3","spread":"0.15"},{"groupId":"OG002","value":"0.1","spread":"0.16"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey","description":"The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) 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":"units on a scale","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"255"}]}],"classes":[{"title":"26 weeks (n=255, 255, 244)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.8","spread":"0.95"},{"groupId":"OG001","value":"-2.4","spread":"0.96"},{"groupId":"OG002","value":"0.3","spread":"0.98"}]}]},{"title":"52 weeks (n=258, 259, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"0.83"},{"groupId":"OG001","value":"-4.1","spread":"0.83"},{"groupId":"OG002","value":"-1.0","spread":"0.86"}]}]},{"title":"78 weeks (n=258, 259, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.6","spread":"0.82"},{"groupId":"OG001","value":"-4.7","spread":"0.82"},{"groupId":"OG002","value":"-2.0","spread":"0.85"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 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 one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. The number of participants with at least 1 TEAE is reported.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"137"}]}]},{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"175"}]}]},{"title":"78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"192"}]}]}]},{"type":"SECONDARY","title":"Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of 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 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Baseline through 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"Severe HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Severe HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}]},{"title":"Severe HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}]},{"title":"Documented symptomatic HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"311"},{"groupId":"OG001","value":"315"},{"groupId":"OG002","value":"447"}]}]},{"title":"Documented symptomatic HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"444"},{"groupId":"OG002","value":"789"}]}]},{"title":"Documented symptomatic HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"607"},{"groupId":"OG001","value":"515"},{"groupId":"OG002","value":"1033"}]}]},{"title":"Asymptomatic HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"500"},{"groupId":"OG001","value":"484"},{"groupId":"OG002","value":"609"}]}]},{"title":"Asymptomatic HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"757"},{"groupId":"OG001","value":"709"},{"groupId":"OG002","value":"1093"}]}]},{"title":"Asymptomatic HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"884"},{"groupId":"OG001","value":"911"},{"groupId":"OG002","value":"1358"}]}]},{"title":"Nocturnal HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"240"}]}]},{"title":"Nocturnal HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"147"},{"groupId":"OG002","value":"519"}]}]},{"title":"Nocturnal HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"184"},{"groupId":"OG002","value":"635"}]}]},{"title":"Probable symptomatic HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"20"}]}]},{"title":"Probable symptomatic HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"22"}]}]},{"title":"Probable symptomatic HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"26"}]}]}]},{"type":"SECONDARY","title":"Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of 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 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"events per participant per year","timeFrame":"Baseline through 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"Severe HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.12"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"0.01","spread":"0.12"}]}]},{"title":"Severe HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.06"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"0.01","spread":"0.09"}]}]},{"title":"Severe HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.06"},{"groupId":"OG001","value":"0.00","spread":"0.00"},{"groupId":"OG002","value":"0.01","spread":"0.06"}]}]},{"title":"Documented symptomatic HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2.35","spread":"5.41"},{"groupId":"OG001","value":"2.52","spread":"6.42"},{"groupId":"OG002","value":"3.64","spread":"6.63"}]}]},{"title":"Documented symptomatic HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2.03","spread":"4.16"},{"groupId":"OG001","value":"1.97","spread":"5.31"},{"groupId":"OG002","value":"3.34","spread":"5.91"}]}]},{"title":"Documented symptomatic HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1.67","spread":"3.58"},{"groupId":"OG001","value":"1.66","spread":"4.96"},{"groupId":"OG002","value":"3.03","spread":"5.63"}]}]},{"title":"Asymptomatic HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3.79","spread":"8.01"},{"groupId":"OG001","value":"3.58","spread":"7.70"},{"groupId":"OG002","value":"4.82","spread":"11.43"}]}]},{"title":"Asymptomatic HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3.08","spread":"6.97"},{"groupId":"OG001","value":"2.68","spread":"5.40"},{"groupId":"OG002","value":"4.41","spread":"8.72"}]}]},{"title":"Asymptomatic HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2.56","spread":"5.90"},{"groupId":"OG001","value":"2.38","spread":"4.95"},{"groupId":"OG002","value":"3.80","spread":"7.24"}]}]},{"title":"Nocturnal HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1.23","spread":"3.84"},{"groupId":"OG001","value":"0.96","spread":"3.53"},{"groupId":"OG002","value":"1.86","spread":"4.84"}]}]},{"title":"Nocturnal HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"3.13"},{"groupId":"OG001","value":"0.65","spread":"2.65"},{"groupId":"OG002","value":"2.07","spread":"4.67"}]}]},{"title":"Nocturnal HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"2.97"},{"groupId":"OG001","value":"0.59","spread":"2.47"},{"groupId":"OG002","value":"1.81","spread":"4.12"}]}]},{"title":"Probable symptomatic HE, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.59"},{"groupId":"OG001","value":"0.14","spread":"1.39"},{"groupId":"OG002","value":"0.15","spread":"0.87"}]}]},{"title":"Probable symptomatic HE, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.07","spread":"0.40"},{"groupId":"OG001","value":"0.09","spread":"0.99"},{"groupId":"OG002","value":"0.08","spread":"0.47"}]}]},{"title":"Probable symptomatic HE, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.32"},{"groupId":"OG001","value":"0.07","spread":"0.67"},{"groupId":"OG002","value":"0.07","spread":"0.37"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks","description":"Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"}]}]},{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"8"}]}]},{"title":"78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"16"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) 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":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"units/liter","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"259"}]}],"classes":[{"title":"Amylase (total), 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"4.000","lowerLimit":"-4.000","upperLimit":"13.000"},{"groupId":"OG001","value":"4.000","lowerLimit":"-3.000","upperLimit":"11.000"},{"groupId":"OG002","value":"2.000","lowerLimit":"-5.000","upperLimit":"8.000"}]}]},{"title":"Amylase (total), 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"4.000","lowerLimit":"-4.000","upperLimit":"11.000"},{"groupId":"OG001","value":"5.000","lowerLimit":"-3.000","upperLimit":"13.000"},{"groupId":"OG002","value":"3.000","lowerLimit":"-5.000","upperLimit":"9.000"}]}]},{"title":"Amylase (total), 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"4.000","lowerLimit":"-4.000","upperLimit":"13.000"},{"groupId":"OG001","value":"4.000","lowerLimit":"-3.000","upperLimit":"12.000"},{"groupId":"OG002","value":"1.000","lowerLimit":"-7.000","upperLimit":"9.000"}]}]},{"title":"Amylase (pancreas-derived), 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3.000","lowerLimit":"-1.000","upperLimit":"8.000"},{"groupId":"OG001","value":"3.000","lowerLimit":"0.000","upperLimit":"7.000"},{"groupId":"OG002","value":"1.000","lowerLimit":"-2.000","upperLimit":"4.000"}]}]},{"title":"Amylase (pancreas-derived), 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3.000","lowerLimit":"-1.000","upperLimit":"8.000"},{"groupId":"OG001","value":"3.000","lowerLimit":"-1.000","upperLimit":"7.000"},{"groupId":"OG002","value":"1.000","lowerLimit":"-2.000","upperLimit":"6.000"}]}]},{"title":"Amylase (pancreas-derived), 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2.000","lowerLimit":"-2.000","upperLimit":"7.000"},{"groupId":"OG001","value":"2.000","lowerLimit":"-1.000","upperLimit":"7.000"},{"groupId":"OG002","value":"0.000","lowerLimit":"-3.000","upperLimit":"4.000"}]}]},{"title":"Lipase, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"5.000","lowerLimit":"-4.000","upperLimit":"15.000"},{"groupId":"OG001","value":"5.000","lowerLimit":"-1.000","upperLimit":"15.000"},{"groupId":"OG002","value":"-1.000","lowerLimit":"-6.000","upperLimit":"5.000"}]}]},{"title":"Lipase, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"4.000","lowerLimit":"-3.000","upperLimit":"12.000"},{"groupId":"OG001","value":"4.000","lowerLimit":"-2.000","upperLimit":"11.000"},{"groupId":"OG002","value":"-1.000","lowerLimit":"-8.000","upperLimit":"6.000"}]}]},{"title":"Lipase, 78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"4.000","lowerLimit":"-3.000","upperLimit":"14.000"},{"groupId":"OG001","value":"4.000","lowerLimit":"-1.000","upperLimit":"13.000"},{"groupId":"OG002","value":"-2.000","lowerLimit":"-8.000","upperLimit":"5.000"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) 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":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"picogram/milliliter","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks (n=266, 267, 258)","categories":[{"measurements":[{"groupId":"OG000","value":"0.163","spread":"1.31"},{"groupId":"OG001","value":"0.097","spread":"1.20"},{"groupId":"OG002","value":"0.149","spread":"1.30"}]}]},{"title":"52 weeks (n=266, 269, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"0.128","spread":"1.20"},{"groupId":"OG001","value":"0.132","spread":"1.32"},{"groupId":"OG002","value":"0.176","spread":"1.62"}]}]},{"title":"78 weeks (n=267, 269, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"0.086","spread":"1.31"},{"groupId":"OG001","value":"0.035","spread":"1.20"},{"groupId":"OG002","value":"0.151","spread":"1.73"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks","description":"Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new 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 at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"Any CV event, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"}]}]},{"title":"Any fatal CV event, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Any non-fatal CV event, 26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"}]}]},{"title":"Any CV event, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"}]}]},{"title":"Any fatal CV event, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Any non-fatal CV event, 52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"5"}]}]},{"title":"Any CV event, 78 week","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"9"}]}]},{"title":"Any fatal CV event, 78 week","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Any non-fatal CV event, 78 week","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"}]}]}]},{"type":"SECONDARY","title":"Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate","description":"Sitting pulse rate was 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":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable sitting pulse rate data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"26 weeks (n=257, 260, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"1.56","spread":"0.49"},{"groupId":"OG001","value":"0.74","spread":"0.48"},{"groupId":"OG002","value":"-1.21","spread":"0.50"}]}]},{"title":"52 weeks (n=250, 252, 240)","categories":[{"measurements":[{"groupId":"OG000","value":"1.29","spread":"0.50"},{"groupId":"OG001","value":"0.51","spread":"0.49"},{"groupId":"OG002","value":"-0.52","spread":"0.51"}]}]},{"title":"78 weeks (n=246, 244, 238)","categories":[{"measurements":[{"groupId":"OG000","value":"1.31","spread":"0.50"},{"groupId":"OG001","value":"0.61","spread":"0.50"},{"groupId":"OG002","value":"-0.91","spread":"0.51"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure","description":"Sitting systolic blood pressure (SBP) and sitting 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":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milliliter of mercury (mmHG)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"SBP, 26 weeks (n=257, 261, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.28","spread":"0.78"},{"groupId":"OG001","value":"-1.60","spread":"0.78"},{"groupId":"OG002","value":"-0.03","spread":"0.80"}]}]},{"title":"SBP, 52 weeks (n=250, 252, 240)","categories":[{"measurements":[{"groupId":"OG000","value":"0.17","spread":"0.81"},{"groupId":"OG001","value":"0.09","spread":"0.80"},{"groupId":"OG002","value":"0.51","spread":"0.83"}]}]},{"title":"SBP, 78 weeks (n=246, 244, 238)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.70","spread":"0.85"},{"groupId":"OG001","value":"-0.59","spread":"0.85"},{"groupId":"OG002","value":"0.51","spread":"0.87"}]}]},{"title":"DBP, 26 weeks (n=257, 261, 245)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.16","spread":"0.49"},{"groupId":"OG001","value":"-0.17","spread":"0.48"},{"groupId":"OG002","value":"-0.29","spread":"0.50"}]}]},{"title":"DBP, 52 weeks (n=250, 252, 240)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.26","spread":"0.48"},{"groupId":"OG001","value":"-0.19","spread":"0.47"},{"groupId":"OG002","value":"-0.93","spread":"0.49"}]}]},{"title":"DBP, 78 weeks (n=246, 244, 238)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.44","spread":"0.52"},{"groupId":"OG001","value":"-0.36","spread":"0.52"},{"groupId":"OG002","value":"-1.04","spread":"0.53"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate","description":"Electrocardiogram (ECG) heart rate was 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":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"260"}]}],"classes":[{"title":"26 weeks (n=241, 247, 231)","categories":[{"measurements":[{"groupId":"OG000","value":"2.64","spread":"0.539"},{"groupId":"OG001","value":"0.90","spread":"0.529"},{"groupId":"OG002","value":"-1.24","spread":"0.549"}]}]},{"title":"52 weeks (n=232, 242, 231)","categories":[{"measurements":[{"groupId":"OG000","value":"2.41","spread":"0.564"},{"groupId":"OG001","value":"0.38","spread":"0.551"},{"groupId":"OG002","value":"-1.01","spread":"0.568"}]}]},{"title":"78 weeks (n=223, 222, 225)","categories":[{"measurements":[{"groupId":"OG000","value":"2.49","spread":"0.592"},{"groupId":"OG001","value":"0.47","spread":"0.588"},{"groupId":"OG002","value":"-0.26","spread":"0.594"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval 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":"Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milliseconds (msec)","timeFrame":"Baseline, 26, 52, and 78 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"},{"id":"OG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"272"},{"groupId":"OG002","value":"262"}]}],"classes":[{"title":"QTcF interval, 26 weeks (n=240, 245, 229)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.71","spread":"0.939"},{"groupId":"OG001","value":"-0.10","spread":"0.926"},{"groupId":"OG002","value":"1.24","spread":"0.962"}]}]},{"title":"QTcF interval, 52 weeks (n=231, 240, 228)","categories":[{"measurements":[{"groupId":"OG000","value":"1.55","spread":"1.074"},{"groupId":"OG001","value":"1.34","spread":"1.054"},{"groupId":"OG002","value":"3.70","spread":"1.088"}]}]},{"title":"QTcF interval, 78 weeks (n=221, 220, 222)","categories":[{"measurements":[{"groupId":"OG000","value":"1.66","spread":"1.045"},{"groupId":"OG001","value":"3.44","spread":"1.039"},{"groupId":"OG002","value":"4.44","spread":"1.053"}]}]},{"title":"PR interval, 26 weeks (n=240, 245, 229)","categories":[{"measurements":[{"groupId":"OG000","value":"2.78","spread":"0.849"},{"groupId":"OG001","value":"2.33","spread":"0.836"},{"groupId":"OG002","value":"1.24","spread":"0.873"}]}]},{"title":"PR interval, 52 weeks (n=230, 240, 227)","categories":[{"measurements":[{"groupId":"OG000","value":"2.61","spread":"0.853"},{"groupId":"OG001","value":"1.88","spread":"0.835"},{"groupId":"OG002","value":"1.50","spread":"0.868"}]}]},{"title":"PR interval, 78 weeks (n=221, 220, 222)","categories":[{"measurements":[{"groupId":"OG000","value":"2.62","spread":"1.034"},{"groupId":"OG001","value":"3.27","spread":"1.026"},{"groupId":"OG002","value":"1.21","spread":"1.043"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)","description":"LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.","populationDescription":"Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline, 26, 52, 78, and 83 weeks","groups":[{"id":"OG000","title":"LY2189265 1.5 mg and 0.75 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"539"}]}],"classes":[{"title":"26 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}]},{"title":"52 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"78 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"83 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"3","eventGroups":[{"id":"EG000","title":"LY2189265 1.5 mg","description":"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks","seriousNumAffected":32,"seriousNumAtRisk":273,"otherNumAffected":199,"otherNumAtRisk":273},{"id":"EG001","title":"LY2189265 0.75 mg","description":"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks\n\nMetformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks","seriousNumAffected":28,"seriousNumAtRisk":272,"otherNumAffected":190,"otherNumAtRisk":272},{"id":"EG002","title":"Insulin Glargine","description":"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks\n\nMetformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks\n\nGlimepiride: at least 4 mg/day, oral, for 78 weeks","seriousNumAffected":33,"seriousNumAtRisk":262,"otherNumAffected":187,"otherNumAtRisk":262}],"seriousEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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arm","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":272},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":262}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":262}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":262}]},{"term":"Ventricular tachycardia","organSystem":"Cardiac 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15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Upper gastrointestinal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":262}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":262}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 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infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Lower respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Mastoiditis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":262}]},{"term":"Osteomyelitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Fall","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Lower limb fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Maternal exposure during pregnancy","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 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15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Post procedural haematoma","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":262}]},{"term":"Skeletal injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":272},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":262}]},{"term":"Spinal fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":273},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":272},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":262}]},{"term":"Tendon rupture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 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