EUCTR2017-002954-35-FIActive, not recruitingPhase 1
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk - AMPLITUDE-O
sanofi-aventis recherche & développement0 sites5,000 target enrollmentStarted: May 18, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 5,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 <60 mL/min and at least one cardiovascular risk factor.
- •-Female patients must agree to follow contraceptive guidance.
- •-Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
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.
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