Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

Novartis

Status and phase: Completed; Phase 4

Conditions: Type II Diabetes Mellitus; Congestive Heart Failure

Treatments: Drug: vildagliptin; Drug: placebo of vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894868

CLAF237A23118

2008-005012-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 798 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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798 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Treatment:

Drug: vildagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo of vildagliptin