Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00099866
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
Inclusion Criteria
- Not currently on durg therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
Exclusion Criteria
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular conditions
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Metformin Comparator - Vildagliptin vildagliptin -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 52 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in body weight at 52 weeks Change from baseline in fasting plasma glucose at 52 weeks Change from baseline in fasting lipids at 52 weeks Adverse event profile after 52 weeks of treatment Change from baseline in HOMA B at 52 weeks
Trial Locations
- Locations (1)
Novartis investigative Site
🇩🇪Investigative Sites, Germany