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Clinical Trial Details

Trial ID: L3913
Source ID: NCT03353350
Associated Drug: Efpeglenatide (Sar439977)
Title: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Acronym: AMPLITUDE-M
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03353350/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: efpeglenatide (SAR439977)|DRUG: placebo
Outcome Measures: Primary: Change in Glycated Hemoglobin (HbA1c) (%), Change from Baseline to Week 30 in HbA1c, Baseline to Week 30 | Secondary: Change in HbA1c (%), Change from Baseline to Week 56 in HbA1c, Baseline to Week 56|Change in Fasting Plasma Glucose (FPG), Change from Baseline to Week 30 in FPG, Baseline to Week 30|HbA1c <7%, Number of participants with HbA1c \<7.0% at Week 30, Week 30|Change in Body Weight at Week 30, Change from Baseline to Week 30 in body weight, Baseline to Week 30|Change in Body Weight at Week 56, Change from Baseline to Week 56 in body weight, Baseline to Week 56|Hypoglycemic Participants, Number of participants with at least 1 hypoglycemic event during treatment period, Baseline to Week 56|Hypoglycemic Events, Number of hypoglycemic events, Baseline to Week 56|Treatment Emergent Adverse Events (TEAEs), Number of participants with TEAEs, Baseline to Week 56
Sponsor/Collaborators: Sponsor: Hanmi Pharmaceutical Company Limited | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 406
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-12-05
Completion Date: 2020-09-07
Results First Posted: 2022-01-18
Last Update Posted: 2022-01-18
Locations: Investigational Site Number 8400004, Birmingham, Alabama, 35205, United States|Investigational Site Number 8400005, Glendale, Arizona, 85306, United States|Investigational Site Number 8400003, Canoga Park, California, 91303, United States|Investigational Site Number 8400007, Chula Vista, California, 91911, United States|Investigational Site Number 8400011, La Mesa, California, 91942, United States|Investigational Site Number 8400009, Los Angeles, California, 90057, United States|Investigational Site Number 8400029, Pomona, California, 91767, United States|Investigational Site Number 8400024, Tarzana, California, 91356, United States|Investigational Site Number 8400026, Van Nuys, California, 91405, United States|Investigational Site Number 8400010, DeLand, Florida, 32720, United States|Investigational Site Number 8400006, Hialeah, Florida, 33012, United States|Investigational Site Number 8400032, West Palm Beach, Florida, 33409, United States|Investigational Site Number 8400025, Lawrenceville, Georgia, 30044, United States|Investigational Site Number 8400034, Chicago, Illinois, 60612, United States|Investigational Site Number 8400033, Kansas City, Missouri, 64128, United States|Investigational Site Number 8400018, Lincoln, Nebraska, 68503, United States|Investigational Site Number 8400062, Las Vegas, Nevada, 89106, United States|Investigational Site Number 8400021, Las Vegas, Nevada, 89109, United States|Investigational Site Number 8400001, Bridgeton, New Jersey, 08302, United States|Investigational Site Number 8400028, Burlington, North Carolina, 27215, United States|Investigational Site Number 8400031, Wilmington, North Carolina, 28401, United States|Investigational Site Number 8400013, Maumee, Ohio, 43537, United States|Investigational Site Number 8400008, Hatboro, Pennsylvania, 19040, United States|Investigational Site Number 8400017, Carrollton, Texas, 75010, United States|Investigational Site Number 8400030, Dallas, Texas, 75230, United States|Investigational Site Number 8400015, Houston, Texas, 77074, United States|Investigational Site Number 8400019, Plano, Texas, 75024, United States|Investigational Site Number 8400020, San Antonio, Texas, 78218, United States|Investigational Site Number 8400016, San Antonio, Texas, 78229, United States|Investigational Site Number 8400027, San Antonio, Texas, 78229, United States|Investigational Site Number 8400023, Schertz, Texas, 78154, United States|Investigational Site Number 8400002, Holladay, Utah, 84117-7054, United States|Investigational Site Number 2760005, Berlin, 12627, Germany|Investigational Site Number 2760003, Frankfurt Am Main, 60313, Germany|Investigational Site Number 2760001, Leipzig, 04103, Germany|Investigational Site Number 6160005, Gdansk, 80-382, Poland|Investigational Site Number 6160004, Gdynia, 81-537, Poland|Investigational Site Number 6160007, Katowice, 40-040, Poland|Investigational Site Number 6160002, Krakow, 31-501, Poland|Investigational Site Number 6160006, Poznan, 60-702, Poland|Investigational Site Number 6160003, Warszawa, 01-192, Poland|Investigational Site Number 6160001, Wroclaw, 50-381, Poland|Investigational Site Number 8040003, Kyiv, 02002, Ukraine|Investigational Site Number 8040001, Kyiv, 03037, Ukraine|Investigational Site Number 8040002, Kyiv, 03049, Ukraine|Investigational Site Number 8040004, Vinnitsa, 21009, Ukraine|Investigational Site Number 8260005, Birmingham, B15 2SQ, United Kingdom|Investigational Site Number 8260004, Cardiff, CF15 9SS, United Kingdom|Investigational Site Number 8260007, Chorley, PR7 7NA, United Kingdom|Investigational Site Number 8260008, Glasgow, G20 0SP, United Kingdom|Investigational Site Number 8260001, Hexham, NE46 1QJ, United Kingdom|Investigational Site Number 8260003, Liverpool, L22 0LG, United Kingdom|Investigational Site Number 8260006, Manchester, M15 6SX, United Kingdom|Investigational Site Number 8260002, Reading, RG2 0TG, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03353350

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress