Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)

Study Overview
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Brief Summary
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This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.

Official Title
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An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy .

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Metformin
* Drug: vildagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese T2D patients who are inadequate controlled (6.5 %< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks), Exclusion Criteria: Type 1 diabetes and secondary diabetes Acute metabolic diabetic complications within the past 3 months. Acute infections which may influence glucose level. Evidence of significant chronic diabetic complications, Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis, FPG > 270 mg/dl (15 mmol/l) Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin up titration<br>metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg) | Drug: Metformin<br>* 500 mg twice daily<br>|
| Experimental: vildagliptin add on to metformin<br>Vildagliptin 50 mg twice daily + Metformin 500mg twice daily | Drug: Metformin<br>* 500 mg twice daily<br>Drug: vildagliptin<br>* Vildagliptin 50 mg twice daily<br>* Other names: LAF237;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin | The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks | baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups | The changes from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analyzed in pre-defined patient subgroups based on Body Mass Index(BMI) ( <24, ≥ 24) and age (<60 y and ≥ 60 y) | baseline and 24 weeks | 
| Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% | The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% of two treatment arms in the overall population and in pre defined sub groups. | baseline and 24 weeks | 
| Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events | The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% without adverse GI events of two treatment arms in the overall population and in pre defined sub groups. | baseline and 24 weeks | 
| Mean change from baseline in fasting plasma glucose (FPG) | Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups. | baseline, 24 weeks | 
| Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample | Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients. | baseline, 24 weeks | 
| Number of patients with adverse events, serious adverse events and death | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes;, vildagliptin;, metformin;