{"protocolSection":{"identificationModule":{"nctId":"NCT01769378","orgStudyIdInfo":{"id":"13193"},"secondaryIdInfos":[{"id":"H9X-MC-GBDG","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)","officialTitle":"A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)","acronym":"AWARD-8"},"statusModule":{"statusVerifiedDate":"2015-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-01"},"primaryCompletionDateStruct":{"date":"2014-12","type":"ACTUAL"},"completionDateStruct":{"date":"2014-12","type":"ACTUAL"},"studyFirstSubmitDate":"2013-01-14","studyFirstSubmitQcDate":"2013-01-14","studyFirstPostDateStruct":{"date":"2013-01-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-09-14","resultsFirstSubmitQcDate":"2015-09-14","resultsFirstPostDateStruct":{"date":"2015-10-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-12-18","lastUpdatePostDateStruct":{"date":"2016-01-25","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":300,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.","interventionNames":["Drug: Placebo","Drug: Glimepiride"]},{"label":"Dulaglutide","type":"EXPERIMENTAL","description":"Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.","interventionNames":["Drug: Dulaglutide","Drug: Glimepiride"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Administered SQ","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SQ","armGroupLabels":["Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Glimepiride","description":"Administered PO","armGroupLabels":["Dulaglutide","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks","description":"Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).","timeFrame":"Baseline, 24 Weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks","description":"The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation \\[GEE\\] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.","timeFrame":"24 Weeks"},{"measure":"Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks","description":"LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in Body Weight at 24 Weeks","description":"LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in Body Mass Index (BMI) at 24 Weeks","description":"LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks","description":"LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Number of Participants With Reported and Adjudicated Cardiovascular Events","description":"Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.","timeFrame":"Baseline through 24 Weeks, 30-day Follow Up"},{"measure":"Number of Participants With Adjudicated Acute Pancreatitis Events","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 24 Weeks, 30-day Follow Up"},{"measure":"Change From Baseline in Calcitonin at 24 Weeks","timeFrame":"Baseline, 24 Weeks"},{"measure":"Percentage of Participants With Self-Reported Events of Hypoglycemia","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =\\<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.","timeFrame":"Baseline through 24 Weeks"},{"measure":"Rate of HE Adjusted Per 30 Days","description":"The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period\\*30 days.","timeFrame":"Baseline through 24 weeks"},{"measure":"Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia","description":"Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.","timeFrame":"Baseline through 24 Weeks"},{"measure":"Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia","description":"An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.","timeFrame":"Baseline through 24 Weeks"},{"measure":"Dulaglutide Anti-Drug Antibodies (ADA)","description":"Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.","timeFrame":"Baseline up to 4 Weeks Post-Last Dose of Study Drug"},{"measure":"Change From Baseline in Lipase","description":"A summary of changes in lipase evaluation from baseline to endpoint.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in Amylase","description":"A summary of changes in amylase evaluation from baseline to endpoint.","timeFrame":"Baseline, 24 Weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit\n* Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit\n* Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol\n* Men and nonpregnant women aged ≥18 years\n* Stable weight (±5%) ≥3 months prior to screening\n* Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m\\^2)\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus\n* Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months prior to the first study visit\n* Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin within 3 months prior to the first study visit is exclusionary\n* Have been treated with drugs that promote weight loss within 3 months prior to the first study visit\n* Are receiving chronic (\\>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit\n* Have had any of the following Cardiovascular (CV) conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident\n* Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery\n* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level \\>2.5 times the upper limit of normal\n* Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit\n* Have an estimated glomerular filtration rate \\[eGFR\\] \\<30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\\^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation as determined by the central laboratory at the first study visit\n* Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B, whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)\n* Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)\n* Have a serum calcitonin ≥20 picogram per milliliter (pg/mL) as determined by the central laboratory at the first study visit","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":"Chino","state":"California","zip":"91710","country":"United States","geoPoint":{"lat":34.01223,"lon":-117.68894}},{"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":"Miami","state":"Florida","zip":"33175","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Trenton","state":"New Jersey","zip":"08611","country":"United States","geoPoint":{"lat":40.21705,"lon":-74.74294}},{"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":"The Bronx","state":"New York","zip":"10461","country":"United States","geoPoint":{"lat":40.84985,"lon":-73.86641}},{"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":"Beaver","state":"Pennsylvania","zip":"15009","country":"United States","geoPoint":{"lat":40.69534,"lon":-80.30478}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Buenos Aires","zip":"(C1056ABJ)","country":"Argentina","geoPoint":{"lat":-34.61315,"lon":-58.37723}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Caba","zip":"C1204AAD","country":"Argentina"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Corrientes","zip":"3400","country":"Argentina","geoPoint":{"lat":-27.46784,"lon":-58.8344}},{"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":"Rosario","zip":"2000","country":"Argentina","geoPoint":{"lat":-32.94682,"lon":-60.63932}},{"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":"Salzburg","zip":"5026","country":"Austria","geoPoint":{"lat":47.79941,"lon":13.04399}},{"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":"Zams","zip":"6511","country":"Austria","geoPoint":{"lat":47.15844,"lon":10.5897}},{"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":"Krapinske Toplice","zip":"49217","country":"Croatia","geoPoint":{"lat":46.09333,"lon":15.84333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Osijek","zip":"31000","country":"Croatia","geoPoint":{"lat":45.55066,"lon":18.6942}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Rijeka","zip":"HR-51000","country":"Croatia","geoPoint":{"lat":45.32673,"lon":14.44241}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Slavonski Brod","zip":"35000","country":"Croatia","geoPoint":{"lat":45.16158,"lon":18.0163}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Varaždin","zip":"42000","country":"Croatia","geoPoint":{"lat":46.30444,"lon":16.33778}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Zagreb","zip":"10000","country":"Croatia","geoPoint":{"lat":45.81444,"lon":15.97798}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mexico City","zip":"06700","country":"Mexico","geoPoint":{"lat":19.42847,"lon":-99.12766}},{"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":"Tampico","zip":"89000","country":"Mexico","geoPoint":{"lat":22.28519,"lon":-97.87777}},{"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":"Alba Iulia","zip":"510053","country":"Romania","geoPoint":{"lat":46.06667,"lon":23.58333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bucharest","zip":"13682","country":"Romania","geoPoint":{"lat":44.43225,"lon":26.10626}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Galati","zip":"800098","country":"Romania","geoPoint":{"lat":45.43687,"lon":28.05028}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Iași","zip":"700547","country":"Romania","geoPoint":{"lat":47.16667,"lon":27.6}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Oradea","zip":"410169","country":"Romania","geoPoint":{"lat":47.0458,"lon":21.91833}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Sibiu","zip":"550371","country":"Romania","geoPoint":{"lat":45.8,"lon":24.15}},{"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":"Celje","zip":"3000","country":"Slovenia","geoPoint":{"lat":46.23092,"lon":15.26044}},{"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":"Ljubljana","zip":"1000","country":"Slovenia","geoPoint":{"lat":46.05108,"lon":14.50513}},{"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":"Bloemfontein","zip":"9301","country":"South Africa","geoPoint":{"lat":-29.12107,"lon":26.214}},{"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":"Durban","zip":"4092","country":"South Africa","geoPoint":{"lat":-29.8579,"lon":31.0292}},{"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":"Somerset West","zip":"7130","country":"South Africa","geoPoint":{"lat":-34.08401,"lon":18.82113}}]},"referencesModule":{"references":[{"pmid":"36894938","type":"DERIVED","citation":"Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Dulaglutide","description":"Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"FG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"240"},{"groupId":"FG001","numSubjects":"60"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"239"},{"groupId":"FG001","numSubjects":"60"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Completed the study on study treatment","numSubjects":"215"},{"groupId":"FG001","comment":"Completed the study on study treatment","numSubjects":"56"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Entry criteria not met","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Intent to treat (ITT) population: all randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"BG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"299"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"182"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"231"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"68"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.73","spread":"10.20"},{"groupId":"BG001","value":"58.23","spread":"7.40"},{"groupId":"BG002","value":"57.83","spread":"9.70"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"135"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"167"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"132"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"112"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"139"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"127"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"160"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"26"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"11"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"202"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"249"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"8"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Argentina","categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"37"}]}]},{"title":"Austria","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]}]},{"title":"Romania","categories":[{"measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"96"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"71"}]}]},{"title":"South Africa","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}]}]},{"title":"Mexico","categories":[{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"50"}]}]},{"title":"Slovenia","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"16"}]}]},{"title":"Croatia","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"11"}]}]},{"title":"Puerto Rico","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks","description":"Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).","populationDescription":"Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change of HbA1c","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.38","spread":"0.08"},{"groupId":"OG001","value":"-0.11","spread":"0.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Squares Mean Difference","paramValue":"-1.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.57","ciUpperLimit":"-0.97","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.15"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks","description":"The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation \\[GEE\\] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.","populationDescription":"Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"53"}]}],"classes":[{"title":"Percent Achieved <7.0 HbA1c Level","categories":[{"measurements":[{"groupId":"OG000","value":"55.3"},{"groupId":"OG001","value":"18.9"}]}]},{"title":"Percent Achieved ≤6.5 HbA1c Level","categories":[{"measurements":[{"groupId":"OG000","value":"40.0"},{"groupId":"OG001","value":"9.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"\\<7.0% HbA1c","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","statisticalComment":"Sequential gatekeeping strategy was used to adjust for multiplicity.","paramType":"Odds Ratio (OR)","paramValue":"11.37","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.82","ciUpperLimit":"33.84"},{"groupIds":["OG000","OG001"],"groupDescription":"≤6.5% HbA1c","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"11.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.71","ciUpperLimit":"35.34"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks","description":"LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).","populationDescription":"Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-30.60","spread":"4.46"},{"groupId":"OG001","value":"2.93","spread":"6.76"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANCOVA","statisticalComment":"Sequential gatekeeping strategy was used to adjust for multiplicity.","paramType":"Least Squares Mean Difference","paramValue":"-33.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.55","ciUpperLimit":"-20.53","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"6.60"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at 24 Weeks","description":"LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.","populationDescription":"Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.91","spread":"0.21"},{"groupId":"OG001","value":"-0.24","spread":"0.40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.120","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Sequential gatekeeping strategy was used to adjust for multiplicity.","paramType":"Least Squares Mean Difference","paramValue":"-0.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.53","ciUpperLimit":"0.18","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.43"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI) at 24 Weeks","description":"LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.","populationDescription":"Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms per/square meter kg/m^2","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.08"},{"groupId":"OG001","value":"-0.10","spread":"0.15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.161","pValueComment":"No adjustment for multiplicity","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.16"}]},{"type":"SECONDARY","title":"Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks","description":"LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.","populationDescription":"Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-37.22","spread":"3.10"},{"groupId":"OG001","value":"-8.27","spread":"4.77"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-28.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-38.49","ciUpperLimit":"-19.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.85"}]},{"type":"SECONDARY","title":"Number of Participants With Reported and Adjudicated Cardiovascular Events","description":"Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.","populationDescription":"ITT population: All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 24 Weeks, 30-day Follow Up","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"60"}]}],"classes":[{"title":"Any reported CV events","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}]},{"title":"Any adjudicated nonfatal CV events","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}]},{"title":"Any confirmed adjudicated CV deaths","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Acute Pancreatitis Events","description":"The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"ITT population: all randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 24 Weeks, 30-day Follow Up","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Calcitonin at 24 Weeks","populationDescription":"Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"picogram per milliliter (pg/ml)","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","lowerLimit":"0.00","upperLimit":"0.00"},{"groupId":"OG001","value":"0.00","lowerLimit":"0.00","upperLimit":"0.00"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Self-Reported Events of Hypoglycemia","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =\\<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.","populationDescription":"ITT Population: all randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"60"}]}],"classes":[{"title":"Symptomatic","categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"1.7"}]}]},{"title":"Asymptomatic","categories":[{"measurements":[{"groupId":"OG000","value":"13.4"},{"groupId":"OG001","value":"1.7"}]}]},{"title":"Probable","categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"0.0"}]}]},{"title":"Severe","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Nocturnal","categories":[{"measurements":[{"groupId":"OG000","value":"6.7"},{"groupId":"OG001","value":"1.7"}]}]}]},{"type":"SECONDARY","title":"Rate of HE Adjusted Per 30 Days","description":"The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period\\*30 days.","populationDescription":"ITT population: all randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"number of events/participants/30 days","timeFrame":"Baseline through 24 weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"60"}]}],"classes":[{"title":"Total HE","categories":[{"measurements":[{"groupId":"OG000","value":"0.19","spread":"0.59"},{"groupId":"OG001","value":"0.01","spread":"0.03"}]}]},{"title":"Documented symptomatic HE","categories":[{"measurements":[{"groupId":"OG000","value":"0.07","spread":"0.33"},{"groupId":"OG001","value":"0.00","spread":"0.02"}]}]},{"title":"Asymptomatic HE","categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"0.45"},{"groupId":"OG001","value":"0.00","spread":"0.02"}]}]},{"title":"Severe HE","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0.0"},{"groupId":"OG001","value":"0","spread":"0.0"}]}]},{"title":"Nocturnal HE","categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"0.16"},{"groupId":"OG001","value":"0.00","spread":"0.02"}]}]},{"title":"Probable symptomatic HE","categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.04"},{"groupId":"OG001","value":"0","spread":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia","description":"Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.","populationDescription":"ITT population: all randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"11.7"}]}]}]},{"type":"SECONDARY","title":"Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia","description":"An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.","populationDescription":"ITT population: All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"weeks","timeFrame":"Baseline through 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.59","spread":"0.36"},{"groupId":"OG001","value":"22.47","spread":"0.66"}]}]}]},{"type":"SECONDARY","title":"Dulaglutide Anti-Drug Antibodies (ADA)","description":"Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.","populationDescription":"ITT population: all randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline up to 4 Weeks Post-Last Dose of Study Drug","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"239"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Lipase","description":"A summary of changes in lipase evaluation from baseline to endpoint.","populationDescription":"All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Units/Liter","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.0","lowerLimit":"1.0","upperLimit":"18.0"},{"groupId":"OG001","value":"4.5","lowerLimit":"-2.5","upperLimit":"15.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Amylase","description":"A summary of changes in amylase evaluation from baseline to endpoint.","populationDescription":"Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Units/Liter","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."},{"id":"OG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"60"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.0","lowerLimit":"1.0","upperLimit":"18.0"},{"groupId":"OG001","value":"2.0","lowerLimit":"-5.0","upperLimit":"11.0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Dulaglutide","description":"Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.","seriousNumAffected":9,"seriousNumAtRisk":239,"otherNumAffected":44,"otherNumAtRisk":239},{"id":"EG001","title":"Placebo","description":"Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.","seriousNumAffected":0,"seriousNumAtRisk":60,"otherNumAffected":3,"otherNumAtRisk":60}],"seriousEvents":[{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Osteomyelitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Otitis media","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Pulmonary tuberculosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Ulna fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Hypoglycemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Rheumatoid arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Anaplastic astrocytoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Cerebrovascular accident","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]}],"otherEvents":[{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":30,"numAffected":20,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":24,"numAffected":14,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":31,"numAffected":25,"numAtRisk":239},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Hyperglycemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":239},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":60}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","phone":"800-545-5979"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","removedCountries":["Brazil","Puerto Rico"]},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C555680","term":"dulaglutide"},{"id":"C057619","term":"glimepiride"}]}},"hasResults":true}