drugset / Trial / NCT01099137

Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin

NCT01099137

Phase 4 Completed 344 enrolled Seoul National University Bundang Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-01
Primary completion
2012-12
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule
Subject Vildagliptin Other / unclassified 50 mg Oral