Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00138567
- Lead Sponsor
- Novartis
- Brief Summary
This is a 52-week extension to a study 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. 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
- 530
Inclusion Criteria
- Only patients successfully completing study CLAF237A2309 are eligible
- Written informed consent
- Ability to comply with all study requirements
Exclusion Criteria
- Premature discontinuation from CLAF237A2309
- 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 fasting plasma glucose between 52 weeks and 104 weeks Change from baseline in fasting plasma glucose at 104 weeks Change from baseline in HOMA B at 104 weeks Change in HOMA B between 52 weeks and 104 weeks Change in HbA1c between 52 weeks and 104 weeks
Trial Locations
- Locations (2)
Novartis Investigative Site
🇺🇸East Hanover, New Jersey, United States
Novartis Investigative site
🇩🇪Investigative Centers, Germany
Novartis Investigative Site🇺🇸East Hanover, New Jersey, United States