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Clinical Trial Details

Trial ID: L4994
Source ID: NCT03713684
Associated Drug: Efpeglenatide Sar439977
Title: 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)
Acronym: AMPLITUDE-L
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03713684/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Efpeglenatide SAR439977|DRUG: Placebo|DRUG: Background therapy
Outcome Measures: Primary: Change From Baseline to Week 30 in HbA1c, Baseline to Week 30 | Secondary: Number of Participants With HbA1c <7.0% at Week 30, Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders., Week 30|Change From Baseline to Week 56 in HbA1c, 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., Baseline to Week 56|Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG), Baseline to Week 30|Change From Baseline to Week 30 and Week 56 in Body Weight, 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., Baseline to Week 30 and Week 56|Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia), 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|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: 370
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-11-09
Completion Date: 2021-01-04
Results First Posted: 2021-12-02
Last Update Posted: 2021-12-02
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 8400057, Huntington Park, California, 90255, United States|Investigational Site Number 8400058, La Jolla, California, 92037, United States|Investigational Site Number 8400009, Los Angeles, California, 90057, 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 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 8400052, West Des Moines, Iowa, 50265, United States|Investigational Site Number 8400044, Lexington, Kentucky, 40503, 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 8400036, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8400013, Maumee, Ohio, 43537, United States|Investigational Site Number 8400030, Dallas, Texas, 75230, United States|Investigational Site Number 8400063, Dallas, Texas, 75390-9302, United States|Investigational Site Number 8400043, San Antonio, Texas, 78229, United States|Investigational Site Number 8400037, Layton, Utah, 84041, United States|Investigational Site Number 1560005, Baotou, 014010, China|Investigational Site Number 1560017, Beijing, 100730, China|Investigational Site Number 1560006, Changsha, 410013, China|Investigational Site Number 1560001, Chengdu, 610083, China|Investigational Site Number 1560004, Shanghai, 014010, China|Investigational Site Number 1560036, Shanghai, 200032, China|Investigational Site Number 1560012, Shanghai, 200040, China|Investigational Site Number 1560013, Shanghai, 200040, China|Investigational Site Number 1560003, Zhengzhou, 450003, China|Investigational Site Number 4100009, Busan, 49241, Korea, Republic of|Investigational Site Number 4100001, Daejeon, 35233, Korea, Republic of|Investigational Site Number 4100016, Gwangju, 501757, Korea, Republic of|Investigational Site Number 4100010, Gwangju, 61453, Korea, Republic of|Investigational Site Number 4100013, Gyeonggi-do, 11765, Korea, Republic of|Investigational Site Number 4100015, Incheon, 21565, Korea, Republic of|Investigational Site Number 4100014, Jeonju, 54907, Korea, Republic of|Investigational Site Number 4100007, Seongnam-Si, 13620, Korea, Republic of|Investigational Site Number 4100008, Seoul, 02447, Korea, Republic of|Investigational Site Number 4100002, Seoul, 03080, Korea, Republic of|Investigational Site Number 4100005, Seoul, 03722, Korea, Republic of|Investigational Site Number 4100004, Seoul, 05278, Korea, Republic of|Investigational Site Number 4100003, Seoul, 06351, Korea, Republic of|Investigational Site Number 4100011, Seoul, 07345, Korea, Republic of|Investigational Site Number 4100006, Seoul, 14647, Korea, Republic of|Investigational Site Number 4100012, Suwon, 16247, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03713684

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress