Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Phase 4
Completed
- Conditions
- Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failureHealth Condition 2: E115- Type 2 diabetes mellitus with circulatory complications
- Registration Number
- CTRI/2009/091/000335
- Lead Sponsor
- ovartis HealthCare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 490
Inclusion Criteria
1. Patients with T2DM, diagnosed at least 3 months prior to Visit 1
2. CHF (NYHA Class I, Class II, or Class III) at Visit 1
3. LVEF < 40%
Exclusion Criteria
1. Pregnant or lactating female
2. FPG and 8805; 270 mgperdL (greater than or equal to15 mmolperL)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).Timepoint: Time Frame: 52 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.Timepoint: Time Frame: 52 weeks;To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.Timepoint: Time Frame: 52 weeks