A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
- Registration Number
- NCT00468039
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
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 type 2 diabetes for at least 4 weeks prior to study entry
- Body mass index 22-40 kg/meter squared
- HbA1c > 11% and/or FPG >270 mg/dL
Exclusion Criteria
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description vildagliptin + metformin vildagliptin + metformin -
- Primary Outcome Measures
Name Time Method glycosylated hemoglobin (HbA1c)at Baseline and week 24 24 weeks
- Secondary Outcome Measures
Name Time Method Weight at baseline and week 24 24 weeks Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks 24 weeks Fasting plasma glucose test (FPG) at Baseline and week 24 24 weeks HbA1c at Baseline and week 12 12 weeks Safety assessed by monitoring and recording all adverse events, serious adverse events. 24 weeks
Trial Locations
- Locations (1)
Diabetes and Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States