Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00382096
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1179
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vildagliptin + Metformin Dose 1 Vildagliptin + Metformin - Vildagliptin + Metformin Dose 2 Vildagliptin + Metformin - Vildagliptin Vildagliptin - Metformin Metformin -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c At week 24
- Secondary Outcome Measures
Name Time Method Percent of patients with endpoint HbA1c <7% At week 24 Change from baseline in fasting plasma glucose At week 24 Percent of patients with reduction in HbA1c >/=0.7% At week 24 Adverse event profile after treatment At week 24 Change from baseline in body weight At week 24
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States