Status:
COMPLETED
A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type...
Eligibility Criteria
Inclusion
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
Exclusion
- Type 1 diabetes
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular conditions
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
639 Patients enrolled
Trial Details
Trial ID
NCT00099905
Start Date
April 1 2004
End Date
October 1 2005
Last Update
May 2 2012
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936