{"protocolSection":{"identificationModule":{"nctId":"NCT03684642","orgStudyIdInfo":{"id":"EFC14829"},"secondaryIdInfos":[{"id":"2017-002956-10","type":"EUDRACT_NUMBER"},{"id":"U1111-1205-3150","type":"OTHER","domain":"UTN"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Sanofi","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin","officialTitle":"A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin","acronym":"AMPLITUDE-D"},"statusModule":{"statusVerifiedDate":"2021-10","overallStatus":"TERMINATED","whyStopped":"Sponsor decision to cancel TRIAL, not related to safety concern.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-09-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-10-13","type":"ACTUAL"},"completionDateStruct":{"date":"2020-11-17","type":"ACTUAL"},"studyFirstSubmitDate":"2018-09-24","studyFirstSubmitQcDate":"2018-09-24","studyFirstPostDateStruct":{"date":"2018-09-26","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-10-04","resultsFirstSubmitQcDate":"2021-10-28","resultsFirstPostDateStruct":{"date":"2021-11-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-10-28","lastUpdatePostDateStruct":{"date":"2021-11-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Sanofi","class":"INDUSTRY"},"collaborators":[{"name":"Hanmi Pharmaceutical Company Limited","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Primary Objective:\n\nTo demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.\n\nSecondary Objectives:\n\n* To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control.\n* To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight.\n* To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.","detailedDescription":"Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE","maskingDescription":"The study was open-label for the tested versus comparator drug and double blind for the doses."}},"enrollmentInfo":{"count":908,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Efpeglenatide 4 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.","interventionNames":["Drug: Efpeglenatide","Drug: Background therapy Metformin"]},{"label":"Efpeglenatide 6 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.","interventionNames":["Drug: Efpeglenatide","Drug: Background therapy Metformin"]},{"label":"Dulaglutide 1.5 mg","type":"ACTIVE_COMPARATOR","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.","interventionNames":["Drug: Dulaglutide","Drug: Background therapy Metformin"]}],"interventions":[{"type":"DRUG","name":"Efpeglenatide","description":"Pharmaceutical form: solution for injection; Route of administration: SC","armGroupLabels":["Efpeglenatide 4 mg","Efpeglenatide 6 mg"],"otherNames":["SAR439977"]},{"type":"DRUG","name":"Dulaglutide","description":"Pharmaceutical form: solution for injection; Route of administration: SC","armGroupLabels":["Dulaglutide 1.5 mg"],"otherNames":["Trulicity™"]},{"type":"DRUG","name":"Background therapy Metformin","description":"Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.","armGroupLabels":["Dulaglutide 1.5 mg","Efpeglenatide 4 mg","Efpeglenatide 6 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to Week 56 in HbA1c","description":"Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.","timeFrame":"Baseline to Week 56"}],"secondaryOutcomes":[{"measure":"Change From Baseline to Week 56 in Body Weight","description":"Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.","timeFrame":"Baseline to Week 56"},{"measure":"Number of Participants With HbA1c < 7.0 %","description":"Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.","timeFrame":"Week 56"},{"measure":"Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)","description":"Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.","timeFrame":"Baseline to Week 56"},{"measure":"Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)","description":"Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<54 milligrams per deciliter (mg/dL) (\\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.","timeFrame":"Baseline up to Week 56"},{"measure":"Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year","description":"Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<54 mg/dL (\\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.","timeFrame":"Baseline up to Week 56"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* Participant must be greater than or equal to (\\>=) 18 years of age at the time of signing the informed consent.\n* Participants with T2DM.\n* Diabetes diagnosed at least 1 year before screening.\n* Participants on stable dose of at least 1500 milligram per day (mg/day) of metformin, or tolerated maximum dose, or as per country regulation if less, for at least 3 months prior to screening.\n* HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening.\n\nExclusion criteria:\n\n* Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery.\n* Clinically relevant history of gastrointestinal (GI) disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease requiring medical treatment within 6 months prior to screening or history of surgery affecting gastric emptying.\n* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.\n* Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).\n* Body weight change of greater than or equal to (\\>=) 5 kilogram within the last 3 months prior to screening.\n* Systolic blood pressure greater than (\\>)180 millimeter of mercury (mmHg) and/or diastolic blood pressure \\>100 mmHg at randomization.\n* Severe renal disease as defined by estimated glomerular filtration rate (eGFR), by Modification of Diet in Renal Disease (MDRD)\\] of less than (\\<)30 mL/min/1.73 m\\^2.\n* Laboratory findings at the screening visit:\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 \\* upper limit of normal (ULN) or total bilirubin \\>1.5 \\* ULN (except in case of documented Gilbert's syndrome);\n* Amylase and/or lipase: \\>3 \\* ULN;\n* Calcitonin \\>=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter).\n* Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to screening, or planned during study period.\n* Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women.\n* Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control or who are unwilling to be tested for pregnancy during the study period and for at least 5 weeks after the last dose of study intervention.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Sciences & Operations","affiliation":"Sanofi","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Investigational Site Number 8400038","city":"Birmingham","state":"Alabama","zip":"35211","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Investigational Site Number 8400035","city":"Chandler","state":"Arizona","zip":"85224","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"Investigational Site Number 8400005","city":"Glendale","state":"Arizona","zip":"85306","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Investigational Site Number 8400054","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Investigational Site Number 8400057","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"Investigational Site Number 8400009","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Investigational Site Number 8400007","city":"San Diego","state":"California","zip":"92120","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Investigational Site Number 8400045","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"Investigational Site Number 8400040","city":"Tustin","state":"California","zip":"92780","country":"United States","geoPoint":{"lat":33.74585,"lon":-117.82617}},{"facility":"Investigational Site Number 8400026","city":"Van Nuys","state":"California","zip":"91405","country":"United States","geoPoint":{"lat":34.18667,"lon":-118.44897}},{"facility":"Investigational Site Number 8400050","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"Investigational Site Number 8400055","city":"Orlando","state":"Florida","zip":"32825","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Investigational Site Number 8400041","city":"Pembroke Pines","state":"Florida","zip":"33026","country":"United States","geoPoint":{"lat":26.00315,"lon":-80.22394}},{"facility":"Investigational Site Number 8400025","city":"Lawrenceville","state":"Georgia","zip":"30044","country":"United States","geoPoint":{"lat":33.95621,"lon":-83.98796}},{"facility":"Investigational Site Number 8400060","city":"Meridian","state":"Idaho","zip":"83642","country":"United States","geoPoint":{"lat":43.61211,"lon":-116.39151}},{"facility":"Investigational Site Number 8400059","city":"Skokie","state":"Illinois","zip":"60077","country":"United States","geoPoint":{"lat":42.03336,"lon":-87.73339}},{"facility":"Investigational Site Number 8400044","city":"Lexington","state":"Kentucky","zip":"40503","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"Investigational Site Number 8400061","city":"Boston","state":"Massachusetts","zip":"02115","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Investigational Site Number 8400001","city":"Bridgeton","state":"New Jersey","zip":"08302","country":"United States","geoPoint":{"lat":39.42734,"lon":-75.23408}},{"facility":"Investigational Site Number 8400039","city":"New Windsor","state":"New York","zip":"12553","country":"United States","geoPoint":{"lat":41.47676,"lon":-74.02375}},{"facility":"Investigational Site Number 8400028","city":"Burlington","state":"North Carolina","zip":"27215","country":"United States","geoPoint":{"lat":36.09569,"lon":-79.4378}},{"facility":"Investigational Site Number 8400036","city":"Morehead City","state":"North Carolina","zip":"28557","country":"United States","geoPoint":{"lat":34.72294,"lon":-76.72604}},{"facility":"Investigational Site Number 8400013","city":"Maumee","state":"Ohio","zip":"43537","country":"United States","geoPoint":{"lat":41.56283,"lon":-83.65382}},{"facility":"Investigational Site Number 8400014","city":"Goose Creek","state":"South Carolina","zip":"29445","country":"United States","geoPoint":{"lat":32.98101,"lon":-80.03259}},{"facility":"Investigational Site Number 8400030","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Investigational Site Number 8400020","city":"San Antonio","state":"Texas","zip":"78218","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Investigational Site Number 8400043","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Investigational Site Number 8400053","city":"San Antonio","state":"Texas","zip":"78258","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Investigational Site Number 8400037","city":"Layton","state":"Utah","zip":"84041","country":"United States","geoPoint":{"lat":41.06022,"lon":-111.97105}},{"facility":"Investigational Site Number 8400049","city":"Manassas","state":"Virginia","zip":"20110","country":"United States","geoPoint":{"lat":38.75095,"lon":-77.47527}},{"facility":"Investigational Site Number 3480004","city":"Budapest","zip":"1036","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Investigational Site Number 3480003","city":"Debrecen","zip":"4025","country":"Hungary","geoPoint":{"lat":47.53167,"lon":21.62444}},{"facility":"Investigational Site Number 3480001","city":"Gyula","zip":"5700","country":"Hungary","geoPoint":{"lat":46.65,"lon":21.28333}},{"facility":"Investigational Site Number 3480005","city":"Hatvan","zip":"3000","country":"Hungary","geoPoint":{"lat":47.66667,"lon":19.68333}},{"facility":"Investigational Site Number 3480002","city":"Nyíregyháza","zip":"4400","country":"Hungary","geoPoint":{"lat":47.95539,"lon":21.71671}},{"facility":"Investigational Site Number 6160008","city":"Gdansk","zip":"80-382","country":"Poland","geoPoint":{"lat":54.35227,"lon":18.64912}},{"facility":"Investigational Site Number 6160004","city":"Gdynia","zip":"81-537","country":"Poland","geoPoint":{"lat":54.51889,"lon":18.53188}},{"facility":"Investigational Site Number 6160010","city":"Katowice","zip":"40-040","country":"Poland","geoPoint":{"lat":50.2597,"lon":19.02173}},{"facility":"Investigational Site Number 6160009","city":"Poznan","zip":"60-702","country":"Poland","geoPoint":{"lat":52.40692,"lon":16.92993}},{"facility":"Investigational Site Number 6160003","city":"Warsaw","zip":"01-192","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"Investigational Site Number 6160001","city":"Wroclaw","zip":"50-381","country":"Poland","geoPoint":{"lat":51.10286,"lon":17.03006}},{"facility":"Investigational Site Number 8040003","city":"Kyiv","zip":"02002","country":"Ukraine","geoPoint":{"lat":50.45466,"lon":30.5238}},{"facility":"Investigational Site Number 8040001","city":"Kyiv","zip":"03037","country":"Ukraine","geoPoint":{"lat":50.45466,"lon":30.5238}},{"facility":"Investigational Site Number 8040002","city":"Kyiv","zip":"03049","country":"Ukraine","geoPoint":{"lat":50.45466,"lon":30.5238}},{"facility":"Investigational Site Number 8040004","city":"Vinnytsia","zip":"21050","country":"Ukraine","geoPoint":{"lat":49.2322,"lon":28.46871}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 908 participants were randomized in 1:1:1 ratio to either efpeglenatide 4 milligram (mg), efpeglenatide 6 mg, or dulaglutide 1.5 mg treatment arms, stratified by screening glycated hemoglobin (HbA1c) values (less than \\[\\<\\]8%, greater than or equal to \\[\\>=\\]8 percent \\[%\\]) and by body mass index (BMI) (\\<30 kg/m\\^2 and \\>=30 kg/m\\^2) on Day 1.","recruitmentDetails":"The study was conducted at 45 active sites in 4 countries. A total of 1608 participants were screened between 26 September 2018 and 17 December 2019, out of which 700 were screen failures. Screen failures were mainly due to inclusion criteria not met.","groups":[{"id":"FG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"FG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"FG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"303"},{"groupId":"FG001","numSubjects":"302"},{"groupId":"FG002","numSubjects":"303"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"303"},{"groupId":"FG001","numSubjects":"302"},{"groupId":"FG002","numSubjects":"302"}]},{"type":"Safety Population","comment":"Participants who received at least 1 dose or part of a dose of the Investigational Medicinal Product (IMP), analyzed according to the treatment actually received.","achievements":[{"groupId":"FG000","comment":"For safety analysis participants are included in the treatment group that they are exposed for longer duration. 10 participants randomized to Efpeglenatide 6 mg received 4 mg dose for longer duration, and considered in the Efpeglenatide 4 mg group for safety analysis.","numSubjects":"313"},{"groupId":"FG001","numSubjects":"292"},{"groupId":"FG002","numSubjects":"302"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"200"},{"groupId":"FG001","numSubjects":"169"},{"groupId":"FG002","numSubjects":"197"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"133"},{"groupId":"FG002","numSubjects":"106"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"53"},{"groupId":"FG002","numSubjects":"23"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Poor compliance to protocol","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Other than specified","reasons":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"60"},{"groupId":"FG002","numSubjects":"67"}]},{"type":"Randomized and not treated","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Missing completion status but alive at last contact","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, analyzed according to the treatment group allocated by randomization.","groups":[{"id":"BG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"BG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"BG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"303"},{"groupId":"BG001","value":"302"},{"groupId":"BG002","value":"303"},{"groupId":"BG003","value":"908"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.3","spread":"9.6"},{"groupId":"BG001","value":"60.0","spread":"10.1"},{"groupId":"BG002","value":"59.4","spread":"10.1"},{"groupId":"BG003","value":"59.9","spread":"9.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"157"},{"groupId":"BG002","value":"153"},{"groupId":"BG003","value":"452"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"161"},{"groupId":"BG001","value":"145"},{"groupId":"BG002","value":"150"},{"groupId":"BG003","value":"456"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"271"},{"groupId":"BG001","value":"263"},{"groupId":"BG002","value":"275"},{"groupId":"BG003","value":"809"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"18"},{"groupId":"BG003","value":"72"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"14"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"9"}]}]},{"title":"Not reported","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilogram per square meter (kg/m^2)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33.4","spread":"6.1"},{"groupId":"BG001","value":"33.4","spread":"6.2"},{"groupId":"BG002","value":"33.4","spread":"6.4"},{"groupId":"BG003","value":"33.4","spread":"6.2"}]}]}]},{"title":"Baseline Glycated Hemoglobin (HbA1c %)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.12","spread":"0.82"},{"groupId":"BG001","value":"8.07","spread":"0.78"},{"groupId":"BG002","value":"8.11","spread":"0.81"},{"groupId":"BG003","value":"8.10","spread":"0.81"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline to Week 56 in HbA1c","description":"Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.","populationDescription":"Analysis was performed on modified intent-to-treat (mITT) population which included participants who completed study treatment; or who discontinued study treatment and completed/discontinued study before early termination; or who discontinued treatment before early termination and discontinued study due to early termination; or who discontinued treatment due to early termination within 30 days of target Week 56 visit.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline to Week 56","groups":[{"id":"OG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"OG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.12","spread":"0.06"},{"groupId":"OG001","value":"-1.17","spread":"0.06"},{"groupId":"OG002","value":"-1.09","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \\<=0.3%.","paramType":"Least Square (LS) Mean difference","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.20","ciUpperLimit":"0.14","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.09"},{"groupIds":["OG001","OG002"],"groupDescription":"A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was \\<=0.3%.","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.09"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7064","pValueComment":"Threshold for significance at the level of 0.05.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3427","pValueComment":"Threshold for significance at the level of 0.05.","statisticalMethod":"ANCOVA"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 56 in Body Weight","description":"Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.","populationDescription":"Analysis was performed on mITT population.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram","timeFrame":"Baseline to Week 56","groups":[{"id":"OG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"OG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.87","spread":"0.64"},{"groupId":"OG001","value":"-3.04","spread":"0.67"},{"groupId":"OG002","value":"-2.81","spread":"0.66"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With HbA1c < 7.0 %","description":"Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.","populationDescription":"Analysis was performed on mITT population.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 56","groups":[{"id":"OG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"OG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"157"},{"groupId":"OG002","value":"150"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)","description":"Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.","populationDescription":"Analysis was performed on mITT population.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline to Week 56","groups":[{"id":"OG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"OG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.81","spread":"0.15"},{"groupId":"OG001","value":"-1.57","spread":"0.15"},{"groupId":"OG002","value":"-1.71","spread":"0.15"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)","description":"Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<54 milligrams per deciliter (mg/dL) (\\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.","populationDescription":"Analysis was performed on safety population.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline up to Week 56","groups":[{"id":"OG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"OG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"313"},{"groupId":"OG001","value":"292"},{"groupId":"OG002","value":"302"}]}],"classes":[{"title":"Documented symptomatic hypoglycemia (<54 mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Severe hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year","description":"Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<54 mg/dL (\\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.","populationDescription":"Analysis was performed on safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events per participant-year","timeFrame":"Baseline up to Week 56","groups":[{"id":"OG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration."},{"id":"OG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration."},{"id":"OG002","title":"Dulaglutide 1.5 mg","description":"Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"313"},{"groupId":"OG001","value":"292"},{"groupId":"OG002","value":"302"}]}],"classes":[{"title":"Documented symptomatic hypoglycemia (<54 mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"0.01"},{"groupId":"OG001","value":"0.01"},{"groupId":"OG002","value":"0"}]}]},{"title":"Severe hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60).","description":"TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.","eventGroups":[{"id":"EG000","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.","deathsNumAffected":0,"deathsNumAtRisk":313,"seriousNumAffected":20,"seriousNumAtRisk":313,"otherNumAffected":202,"otherNumAtRisk":313},{"id":"EG001","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. 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Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.","deathsNumAffected":1,"deathsNumAtRisk":302,"seriousNumAffected":20,"seriousNumAtRisk":302,"otherNumAffected":178,"otherNumAtRisk":302}],"seriousEvents":[{"term":"Covid-19 Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":313},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":302}]},{"term":"Cholecystitis Infective","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":313},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":302}]},{"term":"Atrioventricular Block Complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":313},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":292},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":302}]},{"term":"Cardiac Failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":313},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":302}]},{"term":"Coronary Artery 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