{"protocolSection":{"identificationModule":{"nctId":"NCT03713684","orgStudyIdInfo":{"id":"EFC14893"},"secondaryIdInfos":[{"id":"U1111-1189-5009","type":"OTHER","domain":"UTN"}],"organization":{"fullName":"Sanofi","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)","officialTitle":"A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)","acronym":"AMPLITUDE-L"},"statusModule":{"statusVerifiedDate":"2021-11","overallStatus":"TERMINATED","whyStopped":"Sponsor decision to cancel TRIAL, not related to safety concern","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-11-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-11-20","type":"ACTUAL"},"completionDateStruct":{"date":"2021-01-04","type":"ACTUAL"},"studyFirstSubmitDate":"2018-10-18","studyFirstSubmitQcDate":"2018-10-18","studyFirstPostDateStruct":{"date":"2018-10-22","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-11-04","resultsFirstSubmitQcDate":"2021-11-04","resultsFirstPostDateStruct":{"date":"2021-12-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-11-04","lastUpdatePostDateStruct":{"date":"2021-12-02","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 superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs).\n\nSecondary Objectives:\n\n* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control.\n* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight.\n* To evaluate the safety of once weekly injection of efpeglenatide.","detailedDescription":"Study duration per participant was approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension 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":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":370,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).","interventionNames":["Drug: Placebo","Drug: Background therapy"]},{"label":"Efpeglenatide 2 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.","interventionNames":["Drug: Efpeglenatide SAR439977","Drug: Background therapy"]},{"label":"Efpeglenatide 4 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.","interventionNames":["Drug: Efpeglenatide SAR439977","Drug: Background therapy"]},{"label":"Efpeglenatide 6 mg","type":"EXPERIMENTAL","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.","interventionNames":["Drug: Efpeglenatide SAR439977","Drug: Background therapy"]}],"interventions":[{"type":"DRUG","name":"Efpeglenatide SAR439977","description":"Pharmaceutical form: solution for injection Route of administration: subcutaneous","armGroupLabels":["Efpeglenatide 2 mg","Efpeglenatide 4 mg","Efpeglenatide 6 mg"]},{"type":"DRUG","name":"Placebo","description":"Pharmaceutical form: solution for injection Route of administration: subcutaneous","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Background therapy","description":"Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling.","armGroupLabels":["Efpeglenatide 2 mg","Efpeglenatide 4 mg","Efpeglenatide 6 mg","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to Week 30 in HbA1c","timeFrame":"Baseline to Week 30"}],"secondaryOutcomes":[{"measure":"Number of Participants With HbA1c <7.0% at Week 30","description":"Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.","timeFrame":"Week 30"},{"measure":"Change From Baseline to Week 56 in HbA1c","description":"This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.","timeFrame":"Baseline to Week 56"},{"measure":"Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)","timeFrame":"Baseline to Week 30"},{"measure":"Change From Baseline to Week 30 and Week 56 in Body Weight","description":"This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.","timeFrame":"Baseline to Week 30 and Week 56"},{"measure":"Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and 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 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 basal insulin regimen alone or in combination with OADs for at least 6 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* History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.\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 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.\n* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has 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 predispose to MTC (e.g., multiple endocrine neoplasia syndromes).\n* Body weight change of \\>=5 kilograms within the last 3 months prior to screening.\n* Systolic blood pressure greater than (\\>)180 millimetres of mercury (mmHg) and/or diastolic blood pressure \\>100 mmHg at randomization.\n* End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m\\^2.\n* Laboratory findings at the screening Visit:\n\n  * Alanine aminotransferase or aspartate aminotransferase \\>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 \\[pg/mL\\]).\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 not willing to use highly effective method(s) of birth control or who were 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 8400057","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"Investigational Site Number 8400058","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"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 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 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 8400052","city":"West Des Moines","state":"Iowa","zip":"50265","country":"United States","geoPoint":{"lat":41.57721,"lon":-93.71133}},{"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 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 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 8400030","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Investigational Site Number 8400063","city":"Dallas","state":"Texas","zip":"75390-9302","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"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 8400037","city":"Layton","state":"Utah","zip":"84041","country":"United States","geoPoint":{"lat":41.06022,"lon":-111.97105}},{"facility":"Investigational Site Number 1560005","city":"Baotou","zip":"014010","country":"China","geoPoint":{"lat":40.6516,"lon":109.84389}},{"facility":"Investigational Site Number 1560017","city":"Beijing","zip":"100730","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Investigational Site Number 1560006","city":"Changsha","zip":"410013","country":"China","geoPoint":{"lat":28.19874,"lon":112.97087}},{"facility":"Investigational Site Number 1560001","city":"Chengdu","zip":"610083","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"facility":"Investigational Site Number 1560004","city":"Shanghai","zip":"014010","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Investigational Site Number 1560036","city":"Shanghai","zip":"200032","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Investigational Site Number 1560012","city":"Shanghai","zip":"200040","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Investigational Site Number 1560013","city":"Shanghai","zip":"200040","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Investigational Site Number 1560003","city":"Zhengzhou","zip":"450003","country":"China","geoPoint":{"lat":34.75778,"lon":113.64861}},{"facility":"Investigational Site Number 4100009","city":"Busan","zip":"49241","country":"South Korea","geoPoint":{"lat":35.10168,"lon":129.03004}},{"facility":"Investigational Site Number 4100001","city":"Daejeon","zip":"35233","country":"South Korea","geoPoint":{"lat":36.34913,"lon":127.38493}},{"facility":"Investigational Site Number 4100016","city":"Gwangju","zip":"501757","country":"South Korea","geoPoint":{"lat":35.15472,"lon":126.91556}},{"facility":"Investigational Site Number 4100010","city":"Gwangju","zip":"61453","country":"South Korea","geoPoint":{"lat":35.15472,"lon":126.91556}},{"facility":"Investigational Site Number 4100013","city":"Gyeonggi-do","zip":"11765","country":"South Korea","geoPoint":{"lat":37.58944,"lon":126.76917}},{"facility":"Investigational Site Number 4100015","city":"Incheon","zip":"21565","country":"South Korea","geoPoint":{"lat":37.45646,"lon":126.70515}},{"facility":"Investigational Site Number 4100014","city":"Jeonju","zip":"54907","country":"South Korea","geoPoint":{"lat":35.82194,"lon":127.14889}},{"facility":"Investigational Site Number 4100007","city":"Seongnam-si","zip":"13620","country":"South Korea","geoPoint":{"lat":37.43861,"lon":127.13778}},{"facility":"Investigational Site Number 4100008","city":"Seoul","zip":"02447","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100002","city":"Seoul","zip":"03080","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100005","city":"Seoul","zip":"03722","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100004","city":"Seoul","zip":"05278","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100003","city":"Seoul","zip":"06351","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100011","city":"Seoul","zip":"07345","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100006","city":"Seoul","zip":"14647","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Investigational Site Number 4100012","city":"Suwon","zip":"16247","country":"South Korea","geoPoint":{"lat":37.29111,"lon":127.00889}}]},"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 370 participants were randomized in 1:1:1:1 ratio to either placebo, efpeglenatide 2 milligrams (mg), efpeglenatide 4 mg, or efpeglenatide 6 mg treatment arms, stratified by screening glycated hemoglobin (HbA1c) values (less than \\[\\<\\]8%, greater than or equal to \\[\\>=\\]8%) and sulfonylurea (SU) use at screening (Yes/No).","recruitmentDetails":"The study was conducted at 47 active sites in 3 countries. A total of 540 participants were screened between 09 November 2018 and 02 September 2020, out of which 170 were screen failures. Screen failures were mainly due to inclusion criteria not met.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs)."},{"id":"FG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"FG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"FG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"92"},{"groupId":"FG002","numSubjects":"93"},{"groupId":"FG003","numSubjects":"93"}]},{"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","numSubjects":"92"},{"groupId":"FG001","numSubjects":"92"},{"groupId":"FG002","comment":"For safety analysis participants were included in the treatment arm that they were exposed for longer duration. 3 participants randomized to Efpeglenatide 6 mg arm received 4 mg dose for longer duration; and considered in Efpeglenatide 4 mg arm for safety analysis.","numSubjects":"96"},{"groupId":"FG003","numSubjects":"90"}]},{"type":"Completed 30-Week Core Treatment Period","achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"52"},{"groupId":"FG002","numSubjects":"51"},{"groupId":"FG003","numSubjects":"49"}]},{"type":"COMPLETED","comment":"Completed 56-Week treatment period.","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"87"},{"groupId":"FG002","numSubjects":"88"},{"groupId":"FG003","numSubjects":"87"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Poor compliance to protocol","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"16"}]},{"type":"Other than specified","reasons":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"73"},{"groupId":"FG003","numSubjects":"70"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Analysis was performed on Intent-to-treat (ITT) population which included all participants randomized irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"BG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"BG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"BG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"58.9","spread":"10.7"},{"groupId":"BG001","value":"59.1","spread":"10.7"},{"groupId":"BG002","value":"60.6","spread":"11.5"},{"groupId":"BG003","value":"61.6","spread":"10.3"},{"groupId":"BG004","value":"60.1","spread":"10.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"42"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"173"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"51"},{"groupId":"BG003","value":"53"},{"groupId":"BG004","value":"197"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"51"},{"groupId":"BG003","value":"50"},{"groupId":"BG004","value":"195"}]}]},{"title":"Black or African American","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"36"}]}]},{"title":"Asian","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"34"},{"groupId":"BG004","value":"133"}]}]},{"title":"Other","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"5"}]}]},{"title":"Unknown","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]}]}]},{"title":"Baseline Glycated Hemoglobin (HbA1c %)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of HbA1c","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"370"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.54","spread":"0.83"},{"groupId":"BG001","value":"8.42","spread":"0.79"},{"groupId":"BG002","value":"8.46","spread":"0.79"},{"groupId":"BG003","value":"8.40","spread":"0.72"},{"groupId":"BG004","value":"8.46","spread":"0.78"}]}]}]},{"title":"Body Mass Index (BMI)","populationDescription":"Here, 'number analyzed' = participants with available data for the specified baseline measure.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilogram per square meter (kg/m^2)","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"93"},{"groupId":"BG004","value":"369"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"30.1","spread":"5.6"},{"groupId":"BG001","value":"31.1","spread":"6.1"},{"groupId":"BG002","value":"30.0","spread":"6.6"},{"groupId":"BG003","value":"31.0","spread":"7.1"},{"groupId":"BG004","value":"30.6","spread":"6.4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline to Week 30 in HbA1c","populationDescription":"Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization. Here, \"Overall number of participants analyzed\"= participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline to Week 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"60"},{"groupId":"OG003","value":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.33","spread":"1.09"},{"groupId":"OG001","value":"-1.27","spread":"0.95"},{"groupId":"OG002","value":"-1.24","spread":"0.96"},{"groupId":"OG003","value":"-1.43","spread":"0.94"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With HbA1c <7.0% at Week 30","description":"Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.","populationDescription":"Analysis was performed on ITT population.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"93"},{"groupId":"OG003","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"40"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 56 in HbA1c","description":"This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.","populationDescription":"Analysis was performed on ITT population. Here, \"Overall number of participants analyzed\"= participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline to Week 56","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.86"},{"groupId":"OG001","value":"-1.08","spread":"0.77"},{"groupId":"OG002","value":"-1.23","spread":"0.88"},{"groupId":"OG003","value":"-1.16","spread":"1.34"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)","populationDescription":"Analysis was performed on ITT population. Here, \"Overall number of participants analyzed\"= participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline to Week 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"51"},{"groupId":"OG003","value":"56"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.41","spread":"3.00"},{"groupId":"OG001","value":"-1.34","spread":"2.80"},{"groupId":"OG002","value":"-1.33","spread":"3.52"},{"groupId":"OG003","value":"-2.22","spread":"1.89"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Week 30 and Week 56 in Body Weight","description":"This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.","populationDescription":"Analysis was performed on ITT population. Here, \"Overall number of participants analyzed\"= participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified row.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilograms","timeFrame":"Baseline to Week 30 and Week 56","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG001","title":"Efpeglenatide 2 mg","description":"Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs."},{"id":"OG002","title":"Efpeglenatide 4 mg","description":"Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"61"},{"groupId":"OG003","value":"62"}]}],"classes":[{"title":"Week 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"61"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"3.23"},{"groupId":"OG001","value":"-0.68","spread":"3.63"},{"groupId":"OG002","value":"-1.99","spread":"3.13"},{"groupId":"OG003","value":"-3.14","spread":"3.19"}]}]},{"title":"Week 56","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.66","spread":"3.22"},{"groupId":"OG001","value":"-2.39","spread":"10.69"},{"groupId":"OG002","value":"-1.77","spread":"5.36"},{"groupId":"OG003","value":"-2.85","spread":"4.80"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and 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 mg/dL (\\<3.0 mmol/L). 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Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"96"},{"groupId":"OG003","value":"90"}]}],"classes":[{"title":"Documented symptomatic hypoglycemia (<54 mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"}]}]},{"title":"Severe hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]}]},{"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). 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Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56."},{"id":"OG003","title":"Efpeglenatide 6 mg","description":"Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"96"},{"groupId":"OG003","value":"90"}]}],"classes":[{"title":"Documented symptomatic hypoglycemia (<54 mg/dL)","categories":[{"measurements":[{"groupId":"OG000","value":"0.07"},{"groupId":"OG001","value":"0.27"},{"groupId":"OG002","value":"0.45"},{"groupId":"OG003","value":"0.46"}]}]},{"title":"Severe hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0.09"},{"groupId":"OG001","value":"0.05"},{"groupId":"OG002","value":"0.05"},{"groupId":"OG003","value":"0.04"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). 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23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":92},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":92},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":96},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":90}]},{"term":"Prostate Cancer Metastatic","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":92},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":92},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":96},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":90}]},{"term":"Squamous Cell Carcinoma Of Lung","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 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