Status:
COMPLETED
Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabet...
Eligibility Criteria
Inclusion
- Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
- Agreement to maintain the same dose of metformin from screening to the end of the study
- Age in the range of 18-80 years
- Body mass index (BMI) in the range of 22-40 kg/m2
- HbA1c in the range of 7.0 to 10%
- FPG \<270 mg/dL (15 mmol/L)
Exclusion
- A history of type 1 diabetes
- Liver disease
- Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2665 Patients enrolled
Trial Details
Trial ID
NCT00396227
Start Date
October 1 2006
Last Update
November 18 2016
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936