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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Sulphonylurea dose-up; Drug: Vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01099137

SNUBH_ENDO3

Details and patient eligibility

About

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.

Enrollment: 344 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• HbA1c ≥ 7%
• Age ≥ 18

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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344 participants in 2 patient groups

Vildagliptin

Experimental group

Description:

Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin

Treatment:

Drug: Vildagliptin

Sulphonylurea dose-up

Active Comparator group

Description:

Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin

Treatment:

Drug: Sulphonylurea dose-up