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)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03713684
- 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 basal insulin alone or in combination with oral antidiabetic drugs (OADs).
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 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 370
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efpeglenatide 6 mg Efpeglenatide SAR439977 Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56. Efpeglenatide 2 mg Efpeglenatide SAR439977 Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Efpeglenatide 4 mg Efpeglenatide SAR439977 Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56. Efpeglenatide 2 mg Background therapy Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Placebo Background therapy Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs). Efpeglenatide 4 mg Background therapy Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56. Efpeglenatide 6 mg Background therapy Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56. Placebo Placebo Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 30 in HbA1c Baseline to Week 30
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 56 in HbA1c Baseline to Week 56 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.
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 Baseline to Week 30 and Week 56 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.
Number of Participants With HbA1c <7.0% at Week 30 Week 30 Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia) Baseline up to Week 56 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.
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year Baseline up to Week 56 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.
Trial Locations
- Locations (47)
Investigational Site Number 8400038
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8400035
🇺🇸Chandler, Arizona, United States
Investigational Site Number 8400005
🇺🇸Glendale, Arizona, United States
Investigational Site Number 8400057
🇺🇸Huntington Park, California, United States
Investigational Site Number 8400058
🇺🇸La Jolla, California, United States
Investigational Site Number 8400009
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400045
🇺🇸Spring Valley, California, United States
Investigational Site Number 8400040
🇺🇸Tustin, California, United States
Investigational Site Number 8400026
🇺🇸Van Nuys, California, United States
Investigational Site Number 8400055
🇺🇸Orlando, Florida, United States
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