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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
344
Vildagliptin 50mg twice a day, orally, for 24 weeks
glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin
Seoul National University Bundang Hospital
Seongnam, South Korea
The change of HbA1c
Time frame: 24weeks
Fasting Plasma Glucose (FPG)
Time frame: 24 weeks
Postprandial Plasma Glucose (PPG)
Time frame: 24 weeks
Hypoglycemia
Time frame: 24 weeks
Body weight
Time frame: 24 weeks
HbA1c < 7.0% without hypoglycemia
Time frame: 24 weeks
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