Status:
COMPLETED
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering over...
Eligibility Criteria
Inclusion
- Only patients successfully completing study CLAF237A2329 are eligible
- Written informed consent
- HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units
- Ability to comply with all study requirements
Exclusion
- Premature discontinuation from study CLAF237A2329
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00138593
Start Date
July 1 2004
End Date
July 1 2006
Last Update
March 1 2017
Active Locations (1)
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1
Novartis Pharmaceuticals
Basel, Switzerland