Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Overview
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.
Full Title of Study: “A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2012
Interventions
- Drug: vildagliptin
- Drug: placebo of vildagliptin
Arms, Groups and Cohorts
- Experimental: Vildagliptin
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- 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).
- Time Frame: 52 weeks
Secondary Measures
- 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.
- Time Frame: 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.
- Time Frame: 52 weeks
Participating in This Clinical Trial
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)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Novartis Pharmaceuticals
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
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