Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.

Official Title
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A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy. HbA1c in the range of 7.0-10.0% Body mass index in the range 20-35 kg/m2 Exclusion Criteria: Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily. | Drug: Vildagliptin<br>* vildagliptin 50 mg twice daily<br>* Other names: LAF237;|
| Placebo Comparator: Placebo<br>In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo. | Drug: Placebo<br>* Matching Placebo of vildagliptin 50 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups | HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses | HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory. | Baseline to 12 weeks | 
| Change from baseline in Fasting plasma glucose (FPG) at 12 weeks | FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory. | Baseline to 12 weeks | 
| Percentage of patients meeting Responder rates in HbA1c | Responder rates will be categorized by predefined HbA1c value at 12 weeks : Endpoint HbA1c ≤ 6.5% Endpoint HbA1c ≤ 7% Endpoint HbA1c ≤ 7% in patients with baseline HbA1c ≤ 8% | 12 weeks | 
| Number of patients with adverse events (including hypoglycemia), serious adverse events and death | The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vildagliptin, Type 2 diabetes, HbA1c, Fasting plasma glucose