A multi-center, randomized, double-blind, placebocontrolled 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 - ND
- Conditions
- type 2 diabetes and congestive heart failureMedDRA version: 9.1Level: LLTClassification code 10012647Term: Diabetic cardiomyopathy
- Registration Number
- EUCTR2008-005012-41-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 246
Patients must give written informed consent before any assessment is performed. Patients 18-85 years old (inclusive) at Visit 1. Patients with T2DM, diagnosed at least 3 months prior to Visit 1, either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to Visit 1) and maintaining diet and exercise habits during the full course of the study or treated with anti-diabetic therapy (defined as sulfonylurea, insulin, alpha-glucosidase inhibitors, or glinides as monotherapy or combination therapy for at least 8 weeks prior to Visit 1) and maintaining dietary advice and exercise habits during the full course of the study. Stable dose of anti-diabetic therapy over the past 4 weeks prior to Visit 1 (stable insulin therapy is defined as ± 20% of total daily units) for patients on anti-diabetic treatment. CHF (NYHA Class I, Class II, or Class III) at Visit 1. Treatment of heart failure if required should be according to guidelines [ACC/AHA 2005], [ESC/EASD 2007]. LVEF < 40% (results must be available at Visit 2, prior to randomization) HbA1c in the range of > 6.5% to 10% at Visit 1. Body Mass Index (BMI) in the range of 22-42 kg/m2, inclusive, at Visit 1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method. PLS SEE PROTOCOL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Fasting Plasma Glucose (FPG) ≥ 270 mg/dL (15 mmol/L) at Visit 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL). A history of: type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing?s syndrome and acromegaly. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. Patients that have been enrolled in a vildagliptin clinical trial or taken part in other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within 6 months prior to visit 1. Patients taking vildagliptin at any time.. Patients taking thiazolidinediones (TZDs). TZDs given up to 12 months prior to Visit 1 would be allowed. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study Any of the following within the past 6 months: myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor); coronary artery bypass surgery or percutaneous coronary intervention unstable angina stroke Any of the following ECG abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation second degree AV block (Mobitz 1 and 2); patients with pacemakers are not excluded. PLS SEE PROTOCOL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: 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) after 52 weeks of treatment.;Secondary Objective: Secondary objectives: To evaluate the overall safety and tolerability 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. 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.;Primary end point(s): The primary outcome variable is change from baseline in LVEF (%) at WEEK 52, regardless of rescue medication use. Baseline is the measurement obtained on the day of Screening (WEEK -2, Visit 1).
- Secondary Outcome Measures
Name Time Method