Type 2 diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) > 7%. -Age 18 years or older with established cardiovascular disease or age 50 years (male), 55 years (female) or older with eGFR =25 and =65 years) yes F.1.3.1 Number of subjects for this age range 2000
Exclusion criteria
Exclusion criteria: -Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting. -History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening. -Personal or family history of medullary thyroid cancer (MTC) -Hypertension (with a systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg). -Hospitalization for hypertensive emergency within 3 months prior to randomization -Planned coronary procedure or surgery after randomization. -No documented ophthalmologic exam with fundoscopy within 6 months prior to screening -Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study -Treated with any glucagon-like peptide-1 (GLP-1) receptor agonist products (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening. -Use of any DPP4 inhibitor within 3 months prior to screening -Antihyperglycemic treatment has not been stable within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk.;Secondary Objective: -To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients 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 doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.;Primary end point(s): Time to first Major Adverse Cardiovascular Event (MACE): Time to the first occurrence of any of the following clinical events: cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke;Timepoint(s) of evaluation of this end point: Baseline to approximately 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Time to first expanded cardiovascular outcome event: Time to the first occurrence of any of the following clinical events, positively adjudicated by the clinical endpoint committee (CEC): cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, hospitalization for unstable angina. 2) Time to first composite renal event: Time to the first occurrence of any of the following clinical events: new onset or progression to macro albuminuria (>300 mg/g) accompanied by a urinary albumin-creatinine ratio (UACR) value increase of =30% from baseline, sustained =40% decrease in eGFR from baseline (for =30 days), chronic dialysis (for =90 days), renal transplant, sustained eGFR <15 mL/min/1.73 m2 (for =30 days). 3) Adverse Events (AEs): Number of patients with AEs;Timepoint(s) of evaluation of this end point: 1) to 3) Baseline to approximately 36 months | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Denmark, Estonia, Finland, Germany, Hungary, India, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United States
Outcome results
None listed