Status:
COMPLETED
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering over...
Eligibility Criteria
Inclusion
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
Exclusion
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of significant 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 :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1092 Patients enrolled
Trial Details
Trial ID
NCT00102388
Start Date
January 1 2005
Last Update
November 18 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Investigative Centers, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland