Status:
COMPLETED
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- Diagnosis of T2DM for at least 4 weeks prior to study entry
- Age 18 - 78 years inclusive
- Body mass index (BMI) of 22 - 40 kg/m2
- HbA1c: 7.5 - 11% inclusive
- FPG \<270 mg/dL (15 mmol/L)
- Exclusion Criteria
- Pregnant or lactating female
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2008
Estimated Enrollment :
1179 Patients enrolled
Trial Details
Trial ID
NCT00382096
Start Date
September 1 2006
End Date
June 3 2008
Last Update
December 19 2020
Active Locations (2)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
Multiple Locations, Germany