Status:
COMPLETED
Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-77 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 long-term safety and effectiveness of vildaglipt...
Eligibility Criteria
Inclusion
- On a stable dose of metformin as defined by the protocol
- Blood glucose criteria must be met
- Body mass index (BMI) in the range 22-45
Exclusion
- History of type 1 diabetes
- Pregnancy or lactation
- Evidence of significant diabetic complications
- Serious cardiovascular events within the past 6 months
- Laboratory value abnormalities as defined by the protocol
- Known sensitivity to pioglitazone
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT00237237
Start Date
October 1 2005
Last Update
February 7 2017
Active Locations (2)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
Investigative Centers
Nuremberg, Germany