Status:
COMPLETED
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive 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 vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabet...
Eligibility Criteria
Inclusion
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
Exclusion
- Pregnancy or lactation
- 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 :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
717 Patients enrolled
Trial Details
Trial ID
NCT00099918
Start Date
May 1 2004
End Date
September 1 2005
Last Update
May 17 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
Novartis Investigative Sites
Investigative Centers, Germany