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

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000335

Enrollment

490

Registered

2009-06-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure Health Condition 2: E115- Type 2 diabetes mellitus with circulatory complications

Interventions

Intervention1: Vildagliptin: 50 mg oral tablets for total of 52 weeks. Frequency : qd or bid based on the patientâ??s background use of a sulfonylurea at study entry) Control Intervention1: Vildagl

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating female 2. FPG and 8805; 270 mgperdL (greater than or equal to15 mmolperL)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Czech Republic, Denmark, Estonia, Germany, Guatemala, India, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Slovakia

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026