Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2008/091/000201
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
?On a stable dose of metformin as defined by the protocol
?Blood glucose criteria must be met
?Body mass index (BMI) in the range 22-45
Exclusion Criteria
?Pregnancy or lactation
?Type 1 diabetes
?Evidence of significant diabetic complications
?Evidence of serious cardiovascular complications
?Laboratory value abnormalities as defined by the protocol
?Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Change from baseline in HbA1c at 52 weeksTimepoint: 52 weeks
- Secondary Outcome Measures
Name Time Method ?Adverse event profile after 52 weeks of treatmentTimepoint: 52 weeks of treatment;?Change from baseline in fasting plasma glucose at 52 weeksTimepoint: 52 weeks;?Patients with endpoint HbA1c <7% at 52 weeksTimepoint: 52 weeks;?Patients with reduction in HbA1c >/= 0.5% after 52 weeksTimepoint: 52 weeks;?Patients with reduction in HbA1c >/= 0.7% after 52 weeksTimepoint: 52 weeks