Status:
COMPLETED
Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people...
Eligibility Criteria
Inclusion
- Not currently on drug therapy for type 2 diabetes
- Blood glucose criteria must be met
- Body mass index (BMI) in the range 22-45
Exclusion
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Serious cardiovascular events within the past 6 months
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00120536
Start Date
June 1 2005
End Date
July 1 2006
Last Update
May 18 2017
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936