Congestive Heart Failure, Type II Diabetes Mellitus
Conditions
Keywords
Congestive Heart Failure, CHF, vildagliptin, metabolic disease, cardiovascular disease, T2DM
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.
Interventions
DRUGvildagliptin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
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). | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Czechia, Denmark, Estonia, Germany, Greece, Guatemala, India, Italy, Latvia, Lithuania, Poland, Romania, Russia, Singapore, Slovakia
Outcome results
None listed