Status:
COMPLETED
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagl...
Eligibility Criteria
Inclusion
- Blood glucose criteria must be met
- On a stable dose of metformin as defined by the protocol
- Body mass index (BMI) in the range 22-45
Exclusion
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular complications
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT00099892
Start Date
May 1 2004
End Date
September 1 2005
Last Update
August 2 2017
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936