Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00138606
- Lead Sponsor
- Novartis
- Brief Summary
Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. 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 insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin 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
- 179
Inclusion Criteria
- Only patients successfully completing study CLAF237A2311 are eligible
- Written informed consent
- Ability to comply with all study requirements
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Exclusion Criteria
- Premature discontinuation from CLAF237A2311
- Other protocol-defined exclusion criteria may apply
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 52 weeks Safety of vildagliptin in combination with insulin during 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method Change in HbA1c between 24 weeks and 52 weeks Change from baseline in mean daily number of insulin injections at 52 weeks Change in fasting plasma glucose between 24 weeks and 52 weeks Change from baseline in fasting plasma glucose at 52 weeks Change from baseline in mean daily insulin dose at 52 weeks
Trial Locations
- Locations (2)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States
Novartis Investigative Site
🇩🇪Investigative Centers, Germany