Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00138580
- Lead Sponsor
- Novartis
- Brief Summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone. 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
- 345
Inclusion Criteria
- Only patients successfully completing study CLAF237A2305 are eligible
- Written informed consent
- Ability to comply with all study requirements
Exclusion Criteria
- Premature discontinuation from study CLAF237A2305
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety of vildagliptin in combination with glimepiride during 52 weeks of treatment Change from baseline in HbA1c at 52 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in HOMA B at 52 weeks Change in HbA1c between 24 weeks and 52 weeks Change in fasting plasma glucose between 24 weeks and 52 weeks Change from baseline in HOMA IR at 52 weeks Change from baseline in fasting plasma glucose at 52 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States