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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Sulphonylurea dose-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin | Drug: Vildagliptin<br>* Vildagliptin 50mg twice a day, orally, for 24 weeks<br>* Other names: Galvus;|
| Active Comparator: Sulphonylurea dose-up<br>Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin | Drug: Sulphonylurea dose-up<br>* glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin<br>* Other names: Amaryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of HbA1c |  | 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) |  | 24 weeks | 
| Postprandial Plasma Glucose (PPG) |  | 24 weeks | 
| Hypoglycemia |  | 24 weeks | 
| Body weight |  | 24 weeks | 
| HbA1c < 7.0% without hypoglycemia |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Vildagliptin, insulin, C-peptide