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 from baseline in HOMA B at 104 weeks Change in fasting plasma glucose between 52 weeks and 104 weeks Change from baseline in fasting plasma glucose 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
π©πͺInvestigative Centers, Germany
Novartis Investigative Site
πΊπΈEast Hanover, New Jersey, United States