Effect of Efpeglenatide on Cardiovascular Outcomes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT03496298
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
Secondary Objectives:
To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:
* 3-point MACE.
* Expanded CV outcome.
* Composite outcome of new or worsening nephropathy.
To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
- Detailed Description
The study duration per participant was up to approximately 36 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4076
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment. Efpeglenatide 4 mg Efpeglenatide (SAR439977) Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment. Efpeglenatide 6 mg Efpeglenatide (SAR439977) Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.
- Primary Outcome Measures
Name Time Method Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
- Secondary Outcome Measures
Name Time Method Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months) Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (\>) 300, as measured in mg of albumin to grams of creatinine, or \>33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m\^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.
Trial Locations
- Locations (353)
Investigational Site Number 8400032
🇺🇸Sheffield, Alabama, United States
Investigational Site Number 8400014
🇺🇸Gilbert, Arizona, United States
Investigational Site Number 8400012
🇺🇸Surprise, Arizona, United States
Investigational Site Number 8400046
🇺🇸Tucson, Arizona, United States
Investigational Site Number 8400022
🇺🇸Beverly Hills, California, United States
Investigational Site Number 8400065
🇺🇸Concord, California, United States
Investigational Site Number 8400060
🇺🇸Greenbrae, California, United States
Investigational Site Number 8400084
🇺🇸Long Beach, California, United States
Investigational Site Number 8400002
🇺🇸Los Gatos, California, United States
Investigational Site Number 8400085
🇺🇸Northridge, California, United States
Scroll for more (343 remaining)Investigational Site Number 8400032🇺🇸Sheffield, Alabama, United States