Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin
- Registration Number
- NCT01099137
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.
Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical practice. It is well established that DPP-IV inhibitor improve glycemic control in patients with type 2 diabetes.
But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- Type 2 diabetes
- HbA1c ≥ 7%
- Age ≥ 18
- Contraindication to Vildagliptin
- Pregnant or breast feeding women
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV)
- Liver disease (AST/ALT > 3-fold the upper limit of normal)
- Renal failure (Cr > 2.0)
- Cancer within 5 years
- Not appropriate for oral antidiabetic agent
- Medication which affect glycemic control
- Disease which affect efficacy and safety of drugs
- Other clinical trial within 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sulphonylurea dose-up Sulphonylurea dose-up Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin Vildagliptin Vildagliptin Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin
- Primary Outcome Measures
Name Time Method The change of HbA1c 24weeks
- Secondary Outcome Measures
Name Time Method Fasting Plasma Glucose (FPG) 24 weeks HbA1c < 7.0% without hypoglycemia 24 weeks Hypoglycemia 24 weeks Postprandial Plasma Glucose (PPG) 24 weeks Body weight 24 weeks
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of