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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