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Clinical Trial Details

Trial ID: L5457
Source ID: NCT03684642
Associated Drug: Efpeglenatide
Title: Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Acronym: AMPLITUDE-D
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03684642/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Efpeglenatide|DRUG: Dulaglutide|DRUG: Background therapy Metformin
Outcome Measures: Primary: Change From Baseline to Week 56 in HbA1c, 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., Baseline to Week 56 | Secondary: Change From Baseline to Week 56 in Body Weight, 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., Baseline to Week 56|Number of Participants With HbA1c < 7.0 %, Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders., Week 56|Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG), 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., Baseline to Week 56|Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia), 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., Baseline up to Week 56|Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year, 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., Baseline up to Week 56
Sponsor/Collaborators: Sponsor: Sanofi | Collaborators: Hanmi Pharmaceutical Company Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 908
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09-26
Completion Date: 2020-11-17
Results First Posted: 2021-11-01
Last Update Posted: 2021-11-01
Locations: Investigational Site Number 8400038, Birmingham, Alabama, 35211, United States|Investigational Site Number 8400035, Chandler, Arizona, 85224, United States|Investigational Site Number 8400005, Glendale, Arizona, 85306, United States|Investigational Site Number 8400054, Peoria, Arizona, 85381, United States|Investigational Site Number 8400057, Huntington Park, California, 90255, United States|Investigational Site Number 8400009, Los Angeles, California, 90057, United States|Investigational Site Number 8400007, San Diego, California, 92120, United States|Investigational Site Number 8400045, Spring Valley, California, 91978, United States|Investigational Site Number 8400040, Tustin, California, 92780, United States|Investigational Site Number 8400026, Van Nuys, California, 91405, United States|Investigational Site Number 8400050, Waterbury, Connecticut, 06708, United States|Investigational Site Number 8400055, Orlando, Florida, 32825, United States|Investigational Site Number 8400041, Pembroke Pines, Florida, 33026, United States|Investigational Site Number 8400025, Lawrenceville, Georgia, 30044, United States|Investigational Site Number 8400060, Meridian, Idaho, 83642, United States|Investigational Site Number 8400059, Skokie, Illinois, 60077, United States|Investigational Site Number 8400044, Lexington, Kentucky, 40503, United States|Investigational Site Number 8400061, Boston, Massachusetts, 02115, United States|Investigational Site Number 8400001, Bridgeton, New Jersey, 08302, United States|Investigational Site Number 8400039, New Windsor, New York, 12553, United States|Investigational Site Number 8400028, Burlington, North Carolina, 27215, United States|Investigational Site Number 8400036, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8400013, Maumee, Ohio, 43537, United States|Investigational Site Number 8400014, Goose Creek, South Carolina, 29445, United States|Investigational Site Number 8400030, Dallas, Texas, 75230, United States|Investigational Site Number 8400020, San Antonio, Texas, 78218, United States|Investigational Site Number 8400043, San Antonio, Texas, 78229, United States|Investigational Site Number 8400053, San Antonio, Texas, 78258, United States|Investigational Site Number 8400037, Layton, Utah, 84041, United States|Investigational Site Number 8400049, Manassas, Virginia, 20110, United States|Investigational Site Number 3480004, Budapest, 1036, Hungary|Investigational Site Number 3480003, Debrecen, 4025, Hungary|Investigational Site Number 3480001, Gyula, 5700, Hungary|Investigational Site Number 3480005, Hatvan, 3000, Hungary|Investigational Site Number 3480002, Nyíregyháza, 4400, Hungary|Investigational Site Number 6160008, Gdansk, 80-382, Poland|Investigational Site Number 6160004, Gdynia, 81-537, Poland|Investigational Site Number 6160010, Katowice, 40-040, Poland|Investigational Site Number 6160009, 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, Vinnytsia, 21050, Ukraine
URL: https://clinicaltrials.gov/show/NCT03684642

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details