A study to compare combination regimen with vildagliptin & metformin versus metformin in treatment-naive patients with type 2 diabetes mellitus
- Conditions
- Type 2 Diabetes MellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-003712-23-EE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2000
- T2DM diagnosed =24 months ago
- HbA1c = 6.5% and =7.5% at visit 1
- Treatment-naive
- Body mass index (BMI) = 22 AND=40 kg/M2 at Visit 1
Other protocol-defined inclusion criteria may apply
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
- Pregnant or nursing (lactating) women
- Previous or currrent participation in any vildagliptin clinical study
- History of hypersensitivity to DPP-4 inhibitors
- Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
- Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeeks or planned regular transfusions during the sutdy period
Other protocol-defined exclusion criteria may apply
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