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. - VIVIDD
- Conditions
- Type 2 DiabetesMedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2008-005012-41-SK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 246
1. Patients must give written informed consent before any assessment is performed.
2. Patients 18-85 years old (inclusive) at Visit 1.
3. 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) or treated with anti-diabetic therapy (defined as metformin, 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.
4. 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.
5. CHF (NYHA Class I, Class II, or Class III) at Visit 1.
• Treatment of heart failure should be according to guidelines (SCC/SHS 2005) (ESC/EASD 2007) and dosage of beta-blockers, angiotensin converting
enzyme-inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) should
have been stable for one month prior to visit 1.
6. LVEF < 40% (results must be available at Visit 2, prior to randomization)
7. HbA1c in the range of = 6.5% to 10% at Visit 1.
8. Body Mass Index (BMI) in the range of 22-42 kg/m2, inclusive, at Visit 1.
For detailed inclusion criteria, please refer to the full 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
1. Fasting Plasma Glucose (FPG) = 270 mg/dL (15 mmol/L) at Visit 1.
2. 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).
3. 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.
4. Patients that have been enrolled in a vildagliptin clinical trial or taken other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within 6 months prior to visit 1.
5. Patients taking vildagliptin at any time.
6. Patients taking thiazolidinediones (TZDs). TZDs given up to 6 months prior to Visit 1 are allowed.
7. 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
8. 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
9. 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.
• third degree AV block; patients with pacemakers are not excluded.
• prolonged QTc (> 500 ms) per Bazetts method
10. GFR (estimated by Cockcroft-Gault formula) < 30 mL/min at Visit 1.
11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin),treated or untreated, within the past 5 years, regardless of whether there is evidence of localrecurrence or metastases.
12. Liver disease, such as cirrhosis, or chronic active hepatitis B or C (as defined in exclusion criteria no. 15).
13. Concurrent medical condition that may interfere with the interpretation of safety and efficacy data during the study.
14. Any of the following concomitant medications:
• any anti-diabetic drug therapy other than metformin, sulfonylurea, insulin, alpha-glucosidase inhibitors, or glinides therapy (as monotherapy or combination) within 8 weeks or TZDs within 6 months prior to visit 1
• chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1
• treatment with growth hormones or similar drugs
• treatment with any medication (other than metformin) that is contraindicated in the CHF (NYHA class I-III) population
• use of other investigational drugs within 30 days or 5 half-lives of the drug at visit 1, which ever is longer, unless local health authority guidelines mandate a longer period
• treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e. cytostatic drugs)
15. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
16. Any of the following significant laboratory abnormalities:
• Evidence of active hyper or hypothyroidism interpreted as serum free T4
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method