NCT01099137

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

The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Vildagliptin	Vildagliptin 50mg twice a day, orally, for 24 weeks
DRUG	Sulphonylurea dose-up	glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2010-04-06
• Last updated: 2014-05-28

Locations

1 site across 1 country: South Korea