Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Phase 4
Completed
- Conditions
- Congestive Heart FailureType II Diabetes Mellitus
- Interventions
- Registration Number
- NCT00894868
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 798
Inclusion Criteria
- Patients with T2DM, diagnosed at least 3 months prior to Visit 1
- CHF (NYHA Class I, Class II, or Class III) at Visit 1
- LVEF < 40%
Exclusion Criteria
- Pregnant or lactating female
- FPG ≥ 270 mg/dL (≥15 mmol/L)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo of vildagliptin - Vildagliptin vildagliptin -
- 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). 52 weeks
- Secondary Outcome Measures
Name Time Method 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. 52 weeks 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. 52 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇸🇰Modava Nad Bodvou, Slovakia