To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00368134
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
Inclusion Criteria
- Diagnosis as Type 2 Diabetes
- Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
- Outpatients
Exclusion Criteria
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic complications
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in HbA1c after 12 weeks
- Secondary Outcome Measures
Name Time Method Change in FPG after 12 weeks Change in Fasting Lipids after 12 weeks Change in HOMA-IR after 12 weeks Change in HOMA-B after 12 weeks Safety Profile after 12 weeks treatment
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Tokyo, Japan