Status:
COMPLETED
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- 18-78 years inclusive
- Type 2 diabetes diagnosis at least 2 months prior to study entry
- Body mass index in the range of 22-45 kg/m2
- HbA1c in the range of 6.5 to 9% inclusive
- Fasting plasma glucose \<270 mg/dL (15 mmol/L)
Exclusion
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agents
- Congestive heart failure requiring pharmacologic treatment
- Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females)
- 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 :
914 Patients enrolled
Trial Details
Trial ID
NCT00396357
Start Date
October 1 2006
Last Update
December 17 2020
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 Site
Multiple Locations, Germany