A multicenter, double-blind, randomized study to compare the efficacy of 24 weeks treatment with fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) versus metformin monotherapy (1000 mg bid) in patients with type 2 diabetes inadequately controlled with metformin monotherapy
- Conditions
- Type II Diabetes
- Registration Number
- EUCTR2008-001246-21-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method, based on local regulations (defined in full protocol)
2. Patients with T2DM who have received metformin for at least three months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1. If patients are currently treated with their maximum tolerated dose of metformin but it is < 2000 mg daily, the patients are not eligible for screening. Patients treated with < 2000 mg who have not been previously titrated to a higher dose will start metformin 2000 mg daily at visit 1; if the higher dose is not tolerated, the patients will not be eligible for randomization. Patients receiving a daily dose of metformin > 2000 mg at visit 1 are not eligible.
3. Age in the range of 18-78 years inclusive.
4. Body mass index (BMI) in the range of 22-40 kg/m2 inclusive at visit 1.
5. HbA1c in the range of 7.0 to 9.5% inclusive at visit 1.
6. FPG < 260 mg/dL (14.4 mmol/L) at visit 1.
7. Agreement to maintain prior diet and exercise habits during the full course of the study.
8. Written informed consent to participate in the study and ability to comply with all study requirements.
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. Pregnant or lactating female.
2. 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.
3. Patients taking vildagliptin, other DPP-4 inhibitors, GLP-1 mimetics (e.g. exenatide),
GLP-1 analogues (e.g. liraglutide) within six months prior to visit 1 whether in a clinical trial or as marketed product.
4. 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.
5. 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 clinical trial at the discretion of the investigator and/or local medical monitor);
• unstable angina
• coronary artery bypass surgery or percutaneous coronary intervention;
• stroke
6. Congestive heart failure requiring pharmacologic treatment.
7. Any of the following ECG abnormalities:
• Uncontrolled second (Mobitz 1 and 2) or third degree AV block (patients with
pacemakers that control the AV blocks are eligible)
• prolonged QTc (> 500 ms)
• Torsades de pointes, sustained and clinically relevant ventricular tachycardia or
ventricular fibrillation
8. Malignancy including leukemia and lymphoma (not including basal cell skin cancer)
within the last 5 years.
9. Liver disease such as cirrhosis or chronic active hepatitis B and C.
10. Acromegaly or treatment with growth hormone or similar drugs.
For a full list of the exclusion criteria, please refer to the full protocol.
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