{"protocolSection":{"identificationModule":{"nctId":"NCT03353350","orgStudyIdInfo":{"id":"EFC14822"},"secondaryIdInfos":[{"id":"2016-001857-42"},{"id":"U1111-1182-1806","type":"OTHER","domain":"UTN"},{"id":"2016","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2016"}],"organization":{"fullName":"Hanmi Pharmaceutical Company Limited","class":"INDUSTRY"},"briefTitle":"Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise","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 Diet and 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treatment period, and 6 weeks safety follow up."},"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":406,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Efpeglenatide 2mg","type":"EXPERIMENTAL","description":"Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks","interventionNames":["Drug: efpeglenatide (SAR439977)"]},{"label":"Efpeglenatide 4 mg","type":"EXPERIMENTAL","description":"Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)","interventionNames":["Drug: efpeglenatide (SAR439977)"]},{"label":"Efpeglenatide 6 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laboratory range.\n* Calcitonin ≥5.9 pmol/L (20 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* History of drug or alcohol abuse within 6 months prior to the time of Screening.\n* Pregnant (demonstrated 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 during the study period and for at least 5 weeks after the last dose of study intervention.\n\nThe above information is not intended to contain all considerations relevant to a patient'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 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Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1592-1600. doi: 10.2337/dc21-2656."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Matching placebo (Prefilled syringe) administered once weekly for 56 weeks\n\nplacebo: Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous"},{"id":"FG001","title":"Efpeglenatide 2 mg","description":"Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks\n\nefpeglenatide (SAR439977): Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous"},{"id":"FG002","title":"Efpeglenatide 4 mg","description":"Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)\n\nefpeglenatide (SAR439977): Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous"},{"id":"FG003","title":"Efpeglenatide 6 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