Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Study Details
Study Description
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 metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Safety of vildagliptin in combination with metformin during 52 weeks of treatment []
- Change from baseline in HbA1c at 52 weeks []
Secondary Outcome Measures
- Change in HbA1c between 24 weeks and 52 weeks []
- Change from baseline in fasting plasma glucose at 52 weeks []
- Change in fasting plasma glucose between 24 weeks and 52 weeks []
- Change from baseline in HOMA B at 52 weeks []
- Change from baseline in HOMA IR at 52 weeks []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Only patients successfully completing study CLAF237A2303 are eligible
-
Written informed consent
-
Ability to comply with all study requirements
Exclusion Criteria:
-
Premature discontinuation from CLAF237A2303
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Other protocol-defined exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Pharmaceuticals | East Hanover | New Jersey | United States | 07936 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLAF237A2303E1