EUCTR2017-002954-35-NO
Active, not recruiting
Phase 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes mellitus
- Sponsor
- sanofi-aventis recherche & développement
- Enrollment
- 4076
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<60 mL/min and at least one cardiovascular risk factor.
- •\-Male and 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.
- •\-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) within 3 months prior to screening.
- •\-Use of any DPP4 inhibitor within 12 weeks prior to screening
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Effect of Efpeglenatide on Cardiovascular OutcomesEUCTR2017-002954-35-LTsanofi-aventis recherche & développement5,000
Active, not recruiting
Phase 1
Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabètes Post Worsening Heart Failure (SOLOIST-WHF Trial)EUCTR2017-003510-16-LTexicon Pharmaceuticals, Inc.6,667
Active, not recruiting
Phase 1
A study in LupusPatients with Systemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2015-004404-35-ROEli Lilly and Company314
Active, not recruiting
Phase 1
A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.on-Cystic Fibrosis BronchiectasisTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2017-002533-32-ESInsmed Incorporated240
Active, not recruiting
Phase 1
Study to Evaluate the Efficacy and Safety ofBIIB074 in Subjects With Neuropathic Pain FromLumbosacral RadiculopathyEUCTR2015-004775-78-ROConvergence Pharmaceuticals Ltd424