{"protocolSection":{"identificationModule":{"nctId":"NCT01648582","orgStudyIdInfo":{"id":"13439"},"secondaryIdInfos":[{"id":"H9X-CR-GBDK","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus","officialTitle":"The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea","acronym":"AWARD-CHN2"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-07"},"primaryCompletionDateStruct":{"date":"2014-08","type":"ACTUAL"},"completionDateStruct":{"date":"2014-12","type":"ACTUAL"},"studyFirstSubmitDate":"2012-07-16","studyFirstSubmitQcDate":"2012-07-19","studyFirstPostDateStruct":{"date":"2012-07-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-05-08","resultsFirstSubmitQcDate":"2015-06-29","resultsFirstPostDateStruct":{"date":"2015-07-24","type":"ESTIMATED"},"dispFirstSubmitDate":"2014-09-29","dispFirstSubmitQcDate":"2014-09-29","dispFirstPostDateStruct":{"date":"2014-10-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-09-05","lastUpdatePostDateStruct":{"date":"2019-09-18","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":774,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1.5 mg Dulaglutide","type":"EXPERIMENTAL","description":"1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.","interventionNames":["Drug: Dulaglutide","Drug: Metformin","Drug: Sulfonylureas"]},{"label":"0.75 mg Dulaglutide","type":"EXPERIMENTAL","description":"0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.","interventionNames":["Drug: Dulaglutide","Drug: Metformin","Drug: Sulfonylureas"]},{"label":"Insulin Glargine","type":"ACTIVE_COMPARATOR","description":"Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.","interventionNames":["Drug: Insulin glargine","Drug: Metformin","Drug: Sulfonylureas"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["0.75 mg Dulaglutide","1.5 mg Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Insulin glargine","description":"Administered SC per dosing titration schedule","armGroupLabels":["Insulin Glargine"]},{"type":"DRUG","name":"Metformin","description":"Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.","armGroupLabels":["0.75 mg Dulaglutide","1.5 mg Dulaglutide","Insulin Glargine"]},{"type":"DRUG","name":"Sulfonylureas","description":"Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.","armGroupLabels":["0.75 mg Dulaglutide","1.5 mg Dulaglutide","Insulin Glargine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.","timeFrame":"Baseline, 26 Weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c at 52 Weeks","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.","timeFrame":"Baseline, 52 Weeks"},{"measure":"Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks","description":"The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.","timeFrame":"Up to 26 and 52 weeks"},{"measure":"Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks","description":"LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks","description":"Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks","description":"The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.","timeFrame":"Baseline, 26 weeks, 52 weeks"},{"measure":"Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks","description":"The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Rate of Hypoglycemic Events","description":"Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 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 weeks and 52 weeks"},{"measure":"Number of Self-reported Hypoglycemic Events","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 felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter \\[mmol/L\\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 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 was summarized cumulatively at 52 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 Weeks and 52 Weeks"},{"measure":"Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)","description":"Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate","description":"Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in 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.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in Pancreatic Enzymes","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in Serum Calcitonin","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Number of Participants With Adjudicated Cardiovascular (CV) Events","description":"Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included 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. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 52 weeks"},{"measure":"Number of Participants With Adjudicated Pancreatitis","description":"The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 52 Weeks"},{"measure":"Change From Baseline in Body Weight","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change in Body Mass Index","description":"Body mass index is an estimate of body fat based on body weight divided by height squared.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)","description":"Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.","timeFrame":"Baseline through 52 Weeks"},{"measure":"EQ-5D Health State Score Responses","description":"The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.","timeFrame":"Baseline, 26 Weeks, 52 Weeks"},{"measure":"Change From Baseline in EQ-5D Visual Analog Scale Score","description":"The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.","timeFrame":"Baseline, 26 weeks, 52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have type 2 diabetes mellitus for at least 6 months\n* Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks\n* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%\n* Adult men or adult non-pregnant, non-breastfeeding women\n* Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m\\^2)\n* Stable weight (±5%) ≥3 months prior to screening\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus\n* Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic\n* Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide\n* Have gastric emptying abnormality\n* Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke\n* Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury\\[mmHg\\] or diastolic blood pressure above 95 mmHg)\n* Have impaired liver function\n* Have impaired kidney function\n* Have history of chronic pancreatitis or acute pancreatitis\n* Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)\n* Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)","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":"Beijing","zip":"100730","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"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":"Changsha","zip":"410011","country":"China","geoPoint":{"lat":28.19874,"lon":112.97087}},{"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":"Chengdu","zip":"610041","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"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":"Chongqing","zip":"400030","country":"China","geoPoint":{"lat":29.56026,"lon":106.55771}},{"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":"Dalian","zip":"116011","country":"China","geoPoint":{"lat":38.91222,"lon":121.60222}},{"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":"Guangzhou","zip":"510120","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"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":"Guiyang","zip":"550004","country":"China","geoPoint":{"lat":26.58333,"lon":106.71667}},{"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":"Hangzhou","zip":"310009","country":"China","geoPoint":{"lat":30.29365,"lon":120.16142}},{"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":"Harbin","zip":"150001","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"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":"Hefei","zip":"230022","country":"China","geoPoint":{"lat":31.86389,"lon":117.28083}},{"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":"Nanchang","zip":"330006","country":"China","geoPoint":{"lat":28.68396,"lon":115.85306}},{"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":"Nanjing","zip":"210006","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"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":"Nanning","zip":"530021","country":"China","geoPoint":{"lat":22.81667,"lon":108.31667}},{"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":"Shanghai","zip":"200080","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"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":"Shenyang","zip":"110004","country":"China","geoPoint":{"lat":41.79222,"lon":123.43278}},{"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":"Shijiazhuang","zip":"050051","country":"China","geoPoint":{"lat":38.04139,"lon":114.47861}},{"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":"Wuhan","zip":"430022","country":"China","geoPoint":{"lat":30.58333,"lon":114.26667}},{"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":"Xi'an","zip":"710032","country":"China","geoPoint":{"lat":34.25833,"lon":108.92861}},{"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":"Yangzhou","zip":"225001","country":"China","geoPoint":{"lat":32.39722,"lon":119.43583}},{"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":"Zhenjiang","zip":"212000","country":"China","geoPoint":{"lat":32.21086,"lon":119.45508}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chihuahua City","zip":"31238","country":"Mexico","geoPoint":{"lat":28.63528,"lon":-106.08889}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Monterrey","zip":"64460","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":"Chelyabinsk","zip":"454047","country":"Russia","geoPoint":{"lat":55.1611,"lon":61.42877}},{"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":"Moscow","zip":"127018","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint Petersburg","zip":"190000","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint Petersburg","zip":"192012","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"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":"Kyunggi-Do","zip":"425-020","country":"South Korea"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Seoul","zip":"137-701","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Wŏnju","zip":"220-701","country":"South Korea","geoPoint":{"lat":37.35139,"lon":127.94528}}]},"referencesModule":{"references":[{"pmid":"34580638","type":"DERIVED","citation":"Cai TT, Li HQ, Jiang LL, Wang HY, Luo MH, Su XF, Ma JH. Effects of GLP-1 Receptor Agonists on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus: A 52-Week Clinical Study. Biomed Res Int. 2021 Sep 17;2021:3361309. doi: 10.1155/2021/3361309. eCollection 2021."},{"pmid":"34453682","type":"DERIVED","citation":"Zhou Y, Zhu J, Wu H, Deng Y, Ji Q. Pancreatic Safety of Once-Weekly Dulaglutide in Chinese Patients with Type 2 Diabetes Mellitus: Subgroup Analysis by Potential Influencing Factors. Diabetes Ther. 2021 Oct;12(10):2677-2690. doi: 10.1007/s13300-021-01139-2. Epub 2021 Aug 28."},{"pmid":"33161492","type":"DERIVED","citation":"Ma J, Zhang B, Hou J, Peng Y. Efficacy and Safety of Once Weekly Dulaglutide in East Asian Patients with Type 2 Diabetes: Subgroup Analysis by Potential Influential Factors. Diabetes Ther. 2021 Jan;12(1):211-222. doi: 10.1007/s13300-020-00955-2. Epub 2020 Nov 8."},{"pmid":"32857293","type":"DERIVED","citation":"Kuang J, Zhu J, Liu S, Li Q. Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies. Diabetes Ther. 2020 Oct;11(10):2329-2339. doi: 10.1007/s13300-020-00910-1. Epub 2020 Aug 28."},{"pmid":"32621083","type":"DERIVED","citation":"Guo L, Zhang B, Hou J, Zhou Z. Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials. Diabetes Ther. 2020 Aug;11(8):1821-1833. doi: 10.1007/s13300-020-00869-z. Epub 2020 Jul 4."},{"pmid":"32277401","type":"DERIVED","citation":"Yu M, Yuan GY, Zhang B, Wu HY, Lv XF. Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis. Diabetes Ther. 2020 May;11(5):1147-1159. doi: 10.1007/s13300-020-00804-2. Epub 2020 Apr 10."},{"pmid":"31950036","type":"DERIVED","citation":"Wang J, Li HQ, Xu XH, Kong XC, Sun R, Jing T, Ye L, Su XF, Ma JH. The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus. Biomed Res Int. 2019 Dec 24;2019:2682657. doi: 10.1155/2019/2682657. eCollection 2019."},{"pmid":"31228090","type":"DERIVED","citation":"Li Y, Li L, De Peng Y, Song GY, Ye SD, Du LY, Hou JN, Ji QH. Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2). Diabetes Ther. 2019 Aug;10(4):1435-1452. doi: 10.1007/s13300-019-0646-y. Epub 2019 Jun 21."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This was a parallel-arm, non-inferiority study. Study treatment continued for up to 52 weeks and participants were randomized in a 1:1:1 ratio to one of the 3 treatment arms: 1.5 milligrams (mg) dulaglutide once-weekly , 0.75 mg dulaglutide once-weekly, or insulin glargine once-daily.","groups":[{"id":"FG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"FG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"FG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea."}],"periods":[{"title":"Overall 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Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"83"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of 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Weeks","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 26 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"252"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.73","spread":"0.067"},{"groupId":"OG001","value":"-1.33","spread":"0.067"},{"groupId":"OG002","value":"-1.16","spread":"0.067"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","nonInferiorityComment":"Analyses were based on a pre-defined non-inferiority margin of 0.4%.","paramType":"Mean Difference (Net)","paramValue":"-0.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"-0.40"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","nonInferiorityComment":"Analyses were based on a pre-defined non-inferiority margin of 0.4%.","paramType":"Mean Difference (Net)","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.35","ciUpperLimit":"-0.01"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c at 52 Weeks","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"252"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.47","spread":"0.076"},{"groupId":"OG001","value":"-1.03","spread":"0.076"},{"groupId":"OG002","value":"-0.89","spread":"0.075"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","nonInferiorityComment":"Analyses were based on a pre-defined non-inferiority margin of 0.4%.","paramType":"Mean Difference (Net)","paramValue":"-0.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.77","ciUpperLimit":"-0.38"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","nonInferiorityComment":"Analyses were based on a pre-defined non-inferiority margin of 0.4%.","paramType":"Mean Difference (Net)","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"-0.06"}]},{"type":"SECONDARY","title":"Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks","description":"The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Up to 26 and 52 weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a 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the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or 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2-hours post-meal, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.617","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"0.32"},{"groupIds":["OG000","OG002"],"groupDescription":"Mid-day pre-meal, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.055","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.70","ciUpperLimit":"0.01"},{"groupIds":["OG001","OG002"],"groupDescription":"Mid-day pre-meal, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.855","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference 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2-hours post-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.384","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.67","ciUpperLimit":"0.26"},{"groupIds":["OG000","OG002"],"groupDescription":"Mid-day pre-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.024","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.80","ciUpperLimit":"-0.06"},{"groupIds":["OG001","OG002"],"groupDescription":"Mid-day pre-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.783","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"0.42"},{"groupIds":["OG000","OG002"],"groupDescription":"Mid-day 2-hours post-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.004","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.07","ciUpperLimit":"-0.20"},{"groupIds":["OG001","OG002"],"groupDescription":"Mid-day 2-hours post-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.029","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.92","ciUpperLimit":"-0.05"},{"groupIds":["OG000","OG002"],"groupDescription":"Evening pre-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.01","ciUpperLimit":"-0.27"},{"groupIds":["OG001","OG002"],"groupDescription":"Evening pre-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.603","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.47","ciUpperLimit":"0.27"},{"groupIds":["OG000","OG002"],"groupDescription":"Evening 2-hours post-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.26","ciUpperLimit":"-0.41"},{"groupIds":["OG001","OG002"],"groupDescription":"Evening 2-hours post-meal, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.039","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.87","ciUpperLimit":"-0.02"},{"groupIds":["OG000","OG002"],"groupDescription":"Bedtime, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.39","ciUpperLimit":"-0.60"},{"groupIds":["OG001","OG002"],"groupDescription":"Bedtime, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.003","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.98","ciUpperLimit":"-0.20"}]},{"type":"SECONDARY","title":"Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks","description":"The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HOMA2-%B","timeFrame":"Baseline, 26 weeks, 52 weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"252"}]}],"classes":[{"title":"Insulin-Based HOMA2-%B, 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"34.41","spread":"3.831"},{"groupId":"OG001","value":"31.17","spread":"3.761"}]}]},{"title":"Insulin-Based HOMA2-%B, 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"45.12","spread":"4.147"},{"groupId":"OG001","value":"36.64","spread":"4.061"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%B, Dula 1.5 mg, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.352","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"34.41","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.831"},{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%B, Dula 0.75 mg, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.352","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"31.17","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.761"},{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%B, Dula 1.5, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.025","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"45.12","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.147"},{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%B, Dula 0.75 mg, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.025","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"36.64","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.061"}]},{"type":"SECONDARY","title":"Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks","description":"The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HOMA2-%S","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"252"}]}],"classes":[{"title":"Insulin-Based HOMA2-%S, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-6.86","spread":"3.649"},{"groupId":"OG001","value":"-10.03","spread":"3.591"}]}]},{"title":"Insulin-Based HOMA2-%S, Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"-10.19","spread":"3.677"},{"groupId":"OG001","value":"-12.32","spread":"3.609"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%S, Dula 1.5 mg, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.025","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"36.57","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.977"},{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%S, Dula 0.75 mg, Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.025","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"30.42","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.940"},{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%S, Dula 1.5 mg, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.029","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"41.02","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.900"},{"groupIds":["OG000","OG001"],"groupDescription":"HOMA2-%S, Dula 0.75 mg, Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.029","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"35.19","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.864"}]},{"type":"SECONDARY","title":"Rate of Hypoglycemic Events","description":"Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"events per participant per year","timeFrame":"Baseline through 26 weeks and 52 weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"1-year Rate of HE, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"1.27","spread":"4.485"},{"groupId":"OG001","value":"0.98","spread":"4.202"},{"groupId":"OG002","value":"2.13","spread":"6.724"}]}]},{"title":"Severe HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"NA","spread":"NA","comment":"Data not available because no severe hypoglycemic episodes occurred."},{"groupId":"OG001","value":"NA","spread":"NA","comment":"Data not available because no severe hypoglycemic episodes occurred."},{"groupId":"OG002","value":"NA","spread":"NA","comment":"Data not available because no severe hypoglycemic episodes occurred."}]}]},{"title":"Nocturnal HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0.19","spread":"0.904"},{"groupId":"OG001","value":"0.13","spread":"0.762"},{"groupId":"OG002","value":"0.38","spread":"1.444"}]}]},{"title":"1-year Rate of HE, Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"3.777"},{"groupId":"OG001","value":"0.80","spread":"3.914"},{"groupId":"OG002","value":"1.92","spread":"6.983"}]}]},{"title":"Severe HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"NA","spread":"NA","comment":"Data not available because no severe hypoglycemic episodes occurred."},{"groupId":"OG001","value":"NA","spread":"NA","comment":"Data not available because no severe hypoglycemic episodes occurred."},{"groupId":"OG002","value":"NA","spread":"NA","comment":"Data not available because no severe hypoglycemic episodes occurred."}]}]},{"title":"Nocturnal HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"0.488"},{"groupId":"OG001","value":"0.10","spread":"0.551"},{"groupId":"OG002","value":"0.31","spread":"1.261"}]}]}]},{"type":"SECONDARY","title":"Number of Self-reported Hypoglycemic Events","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 felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter \\[mmol/L\\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 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 was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 26 Weeks and 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Total HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"19.4"},{"groupId":"OG001","value":"16.7"},{"groupId":"OG002","value":"29.6"}]}]},{"title":"Severe HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]},{"title":"Nocturnal HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"6.2"},{"groupId":"OG001","value":"3.9"},{"groupId":"OG002","value":"11.1"}]}]},{"title":"Documented Symptomatic Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"11.2"},{"groupId":"OG001","value":"7.8"},{"groupId":"OG002","value":"17.0"}]}]},{"title":"Asymptomatic HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"10.1"},{"groupId":"OG001","value":"8.2"},{"groupId":"OG002","value":"14.2"}]}]},{"title":"Probable HE Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4.3"},{"groupId":"OG001","value":"5.1"},{"groupId":"OG002","value":"7.5"}]}]},{"title":"Total HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"22.5"},{"groupId":"OG001","value":"19.8"},{"groupId":"OG002","value":"34.8"}]}]},{"title":"Severe HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]},{"title":"Nocturnal HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"7.0"},{"groupId":"OG001","value":"4.3"},{"groupId":"OG002","value":"13.8"}]}]},{"title":"Documented Symptomatic HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"12.4"},{"groupId":"OG001","value":"9.7"},{"groupId":"OG002","value":"20.6"}]}]},{"title":"Asymptomatic HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"12.0"},{"groupId":"OG001","value":"10.1"},{"groupId":"OG002","value":"19.4"}]}]},{"title":"Probable HE Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"4.7"},{"groupId":"OG001","value":"5.4"},{"groupId":"OG002","value":"8.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)","description":"Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)]","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"SBP 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-5.53","spread":"12.037"},{"groupId":"OG001","value":"-2.77","spread":"11.920"},{"groupId":"OG002","value":"-2.22","spread":"12.743"}]}]},{"title":"DBP 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.58","spread":"7.842"},{"groupId":"OG001","value":"-0.92","spread":"7.898"},{"groupId":"OG002","value":"-1.61","spread":"8.417"}]}]},{"title":"SBP 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-2.18","spread":"11.134"},{"groupId":"OG001","value":"-0.61","spread":"12.081"},{"groupId":"OG002","value":"-0.25","spread":"11.717"}]}]},{"title":"DBP 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-0.19","spread":"7.542"},{"groupId":"OG001","value":"0.44","spread":"7.582"},{"groupId":"OG002","value":"-1.13","spread":"8.810"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 26 SBP","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.008","pValueComment":"Overall p-value","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 26 DBP","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.584","pValueComment":"Overall p-value","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 52 SBP","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.169","pValueComment":"Overall p-value","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 52 DBP","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.110","pValueComment":"Overall p-value","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate","description":"Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Change From Baseline on Pulse rate at Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4.63","spread":"8.681"},{"groupId":"OG001","value":"0.65","spread":"8.631"},{"groupId":"OG002","value":"-0.86","spread":"9.546"}]}]},{"title":"Change From Baseline on Pulse rate at Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"4.18","spread":"8.336"},{"groupId":"OG001","value":"3.18","spread":"8.917"},{"groupId":"OG002","value":"0.07","spread":"8.205"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","pValueComment":"Overall p-value","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","pValueComment":"Overall p-value","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline in 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.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millisecond (msec)","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"QTcF Interval 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-1.65","spread":"13.157"},{"groupId":"OG001","value":"0.76","spread":"11.643"},{"groupId":"OG002","value":"2.56","spread":"11.911"}]}]},{"title":"PR Interval 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3.09","spread":"1.700"},{"groupId":"OG001","value":"2.88","spread":"10.801"},{"groupId":"OG002","value":"-0.86","spread":"10.272"}]}]},{"title":"QTcF Interval 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"0.55","spread":"11.209"},{"groupId":"OG001","value":"1.19","spread":"12.165"},{"groupId":"OG002","value":"4.03","spread":"11.446"}]}]},{"title":"PR Interval 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"3.60","spread":"12.425"},{"groupId":"OG001","value":"3.55","spread":"11.526"},{"groupId":"OG002","value":"0.63","spread":"11.861"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"6.13","spread":"8.924"},{"groupId":"OG001","value":"3.77","spread":"9.002"},{"groupId":"OG002","value":"-0.46","spread":"9.329"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"5.04","spread":"8.223"},{"groupId":"OG001","value":"3.40","spread":"7.986"},{"groupId":"OG002","value":"0.43","spread":"8.060"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Pancreatic Enzymes","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug. 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":"Units/Liter (U/L)","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Amylase, Total 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"7.50","spread":"18.755"},{"groupId":"OG001","value":"7.54","spread":"22.388"},{"groupId":"OG002","value":"-0.37","spread":"18.196"}]}]},{"title":"Amylase, pancreas derived 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"5.83","spread":"14.607"},{"groupId":"OG001","value":"5.14","spread":"19.360"},{"groupId":"OG002","value":"-0.21","spread":"11.287"}]}]},{"title":"Lipase 26 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"11.00","spread":"34.134"},{"groupId":"OG001","value":"10.67","spread":"39.989"},{"groupId":"OG002","value":"-2.74","spread":"21.818"}]}]},{"title":"Amylase, Total 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"7.82","spread":"16.250"},{"groupId":"OG001","value":"6.42","spread":"20.675"},{"groupId":"OG002","value":"0.64","spread":"18.696"}]}]},{"title":"Amylase, pancreas derived 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"5.48","spread":"12.449"},{"groupId":"OG001","value":"4.05","spread":"15.490"},{"groupId":"OG002","value":"-0.49","spread":"12.576"}]}]},{"title":"Lipase 52 Weeks","categories":[{"measurements":[{"groupId":"OG000","value":"10.76","spread":"27.360"},{"groupId":"OG001","value":"9.64","spread":"33.715"},{"groupId":"OG002","value":"-3.66","spread":"20.484"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Serum Calcitonin","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug. Only pre-rescue measurements were used. 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":"picomole/liter","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.240"},{"groupId":"OG001","value":"-0.07","spread":"0.289"},{"groupId":"OG002","value":"0.02","spread":"0.256"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.279"},{"groupId":"OG001","value":"-0.08","spread":"0.325"},{"groupId":"OG002","value":"-0.05","spread":"0.306"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Cardiovascular (CV) Events","description":"Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included 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. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants with adjudicated CV events","timeFrame":"Baseline through 52 weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Pancreatitis","description":"The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-1.47","spread":"0.197"},{"groupId":"OG001","value":"-0.88","spread":"0.197"},{"groupId":"OG002","value":"0.97","spread":"0.198"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"-1.08","spread":"0.201"},{"groupId":"OG001","value":"-0.76","spread":"0.202"},{"groupId":"OG002","value":"1.35","spread":"0.201"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","pValueComment":"Week 26","statisticalMethod":"Mixed Models Analysis","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Body Mass Index","description":"Body mass index is an estimate of body fat based on body weight divided by height squared.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram/square meter (kg/m2)","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-0.53","spread":"0.071"},{"groupId":"OG001","value":"-0.32","spread":"0.071"},{"groupId":"OG002","value":"0.37","spread":"0.071"}]}]},{"title":"Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","spread":"0.072"},{"groupId":"OG001","value":"-0.27","spread":"0.072"},{"groupId":"OG002","value":"0.52","spread":"0.072"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Week 26","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Week 52","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)","description":"Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.","populationDescription":"Participants in the safety population who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline through 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Participants with >=1 TE Dula ADA","categories":[{"measurements":[{"groupId":"OG000","value":"3.9"},{"groupId":"OG001","value":"4.3"},{"groupId":"OG002","value":"1.6"}]}]},{"title":"Participants with TE Dula ADA and Neutralizing","categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"1.6"},{"groupId":"OG002","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"EQ-5D Health State Score Responses","description":"The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline, 26 Weeks, 52 Weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"253"}]}],"classes":[{"title":"Mobility - no problem Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"215"},{"groupId":"OG002","value":"210"}]}]},{"title":"Mobility - some problem Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"20"}]}]},{"title":"Mobility - extreme problem Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Mobility - missing Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"Self-care - no problem Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"227"},{"groupId":"OG002","value":"224"}]}]},{"title":"Self-care - some problem Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Self-care - extreme problem Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Self-care - missing Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"Usual activities - no problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"220"},{"groupId":"OG002","value":"218"}]}]},{"title":"Usual activities - some problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"11"}]}]},{"title":"Usual activities - extreme problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Usual activities - missing Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"Pain/Discomfort - no problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"193"},{"groupId":"OG001","value":"201"},{"groupId":"OG002","value":"188"}]}]},{"title":"Pain/Discomfort - some problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"37"}]}]},{"title":"Pain/Discomfort - ambiguous","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Pain/Discomfort - missing Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"Anxiety/Depression - no problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"203"}]}]},{"title":"Anxiety/Depression - some problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"26"}]}]},{"title":"Anxiety/Depression - extreme problems Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Anxiety/Depression - missing Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"Mobility - no problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"207"},{"groupId":"OG002","value":"214"}]}]},{"title":"Mobility - some problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"16"}]}]},{"title":"Mobility - extreme problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Mobility - missing Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Self-care - 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extreme problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Usual Activities - missing Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Pain/Discomfort - no problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"185"}]}]},{"title":"Pain/Discomfort - some problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"43"}]}]},{"title":"Pain/Discomfort - extreme problems Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Pain/Discomfort - missing Week 52","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Anxiety/Depression - 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Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.","populationDescription":"Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 26 weeks, 52 weeks","groups":[{"id":"OG000","title":"1.5 mg Dulaglutide","description":"1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG001","title":"0.75 mg Dulaglutide","description":"0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea."},{"id":"OG002","title":"Insulin Glargine","description":"Insulin glargine administered per dosing titration schedule as once daily SC 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