Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT03770728
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To 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 metformin alone or in combination with sulfonylurea (SU).
Secondary Objectives:
* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control.
* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight.
* To evaluate the safety of once weekly injection of efpeglenatide.
- Detailed Description
Study duration per participant was approximately 39 weeks including an up to 3-week Screening Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 312
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efpeglenatide 2 mg Efpeglenatide SAR439977 Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Efpeglenatide 4 mg Efpeglenatide SAR439977 Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30. Efpeglenatide 6 mg Efpeglenatide SAR439977 Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30. Placebo Placebo Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 30 in HbA1c Baseline to Week 30 This analysis included all Week 30 assessment values available.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 30 in Body Weight Baseline to Week 30 This analysis included all Week 30 assessment values available.
Number of Participants With HbA1c <7.0% Week 30 Participants who had no available assessment for HbA1c \<7% at Week 30 were considered as non-responders.
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year Baseline up to Week 30 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.
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG) Baseline to Week 30 This analysis included all Week 30 assessment values available.
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia) Baseline up to Week 30 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.
Related Research Topics
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Trial Locations
- Locations (48)
Investigational Site Number 8400035
🇺🇸Chandler, Arizona, United States
Investigational Site Number 8400005
🇺🇸Glendale, Arizona, United States
Investigational Site Number 8400056
🇺🇸Tucson, Arizona, United States
Investigational Site Number 8400001
🇺🇸Bridgeton, New Jersey, United States
Investigational Site Number 1560051
🇨🇳Hefei, China
Investigational Site Number 8400038
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8400042
🇺🇸Mesa, Arizona, United States
Investigational Site Number 8400051
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 8400009
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400040
🇺🇸Tustin, California, United States
Investigational Site Number 8400045
🇺🇸Spring Valley, California, United States
Investigational Site Number 8400025
🇺🇸Lawrenceville, Georgia, United States
Investigational Site Number 8400046
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 8400041
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number 8400047
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 8400044
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 8400030
🇺🇸Dallas, Texas, United States
Investigational Site Number 8400039
🇺🇸New Windsor, New York, United States
Investigational Site Number 8400036
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 8400013
🇺🇸Maumee, Ohio, United States
Investigational Site Number 8400048
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 8400043
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8400037
🇺🇸Layton, Utah, United States
Investigational Site Number 1560042
🇨🇳Beijing, China
Investigational Site Number 1560005
🇨🇳Baotou, China
Investigational Site Number 1560053
🇨🇳Hangzhou, China
Investigational Site Number 1560055
🇨🇳Nanchang, China
Investigational Site Number 1560025
🇨🇳Meihekou, China
Investigational Site Number 1560011
🇨🇳Hunan, China
Investigational Site Number 1560024
🇨🇳Nanjing, China
Investigational Site Number 1560020
🇨🇳Pingxiang, China
Investigational Site Number 1560031
🇨🇳Shandong, China
Investigational Site Number 1560012
🇨🇳Shanghai, China
Investigational Site Number 1560030
🇨🇳Shandong, China
Investigational Site Number 1560013
🇨🇳Shanghai, China
Investigational Site Number 1560004
🇨🇳Shanghai, China
Investigational Site Number 1560041
🇨🇳Tianjin, China
Investigational Site Number 1560022
🇨🇳Shanghai, China
Investigational Site Number 1560010
🇨🇳Wenzhou, China
Investigational Site Number 1560052
🇨🇳Wuhu, China
Investigational Site Number 1560034
🇨🇳Wuxi, China
Investigational Site Number 1560044
🇨🇳Yichun, China
Investigational Site Number 1560026
🇨🇳Xuzhou, China
Investigational Site Number 1560003
🇨🇳Zhengzhou, China
Investigational Site Number 1580002
🇨🇳Taipei, Taiwan
Investigational Site Number 1580006
🇨🇳Kaohsiung, Taiwan
Investigational Site Number 1580003
🇨🇳Taichung, Taiwan
Investigational Site Number 8400057
🇺🇸Huntington Park, California, United States