A study to test if aleglitazar has a positive effect on the heart of patients with Type 2 diabetes and without cardiac disease, looking at the way the heart processes energy and fat.
- Conditions
- Type 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-001639-29-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Men and women 40 to 70 years of age;
T2D patients either drug-naïve (i.e., treated with diet and exercise) or treated with stable metformin monotherapy;
HbA1c = 7.0% and = 9.0%;
absence of history of coronary artery disease.
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 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 6
Treatment with fibrates, TZDs or insulin;
intolerance to thiazolidinediones, and/or fibrates;
known chronic diabetic complications;
clinically significant hepatic disease and/or liver tests abnormalities;
symptomatic congestive heart failure classified as NYHA class II-IV;
malignancy within the past 5 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method