Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00138619
- Lead Sponsor
- Novartis
- Brief Summary
This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 478
Inclusion Criteria
- Only patients successfully completing study CLAF237A2327 are eligible
- Written informed consent
- Ability to comply with all study requirements
Exclusion Criteria
- Premature discontinuation from study CLAF237A2327
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety during 104 weeks of treatment Change from baseline in HbA1c at 104 weeks
- Secondary Outcome Measures
Name Time Method Change in HbA1c between 24 weeks and 104 weeks Change from baseline in fasting plasma glucose at 104 weeks Change in fasting plasma glucose between 24 weeks and 104 weeks Change from baseline in HOMA B at 104 weeks Change in HOMA B between 24 weeks and 104 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States