Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The study design of this trial is open-label, randomized, multi-center, parallel-group study.

Detailed Description
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The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability. Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP. Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary. Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.

Official Title
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A 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
* Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0 11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit Age of 18-80 years Body Mass Index of 18-40 kg/m2 Exclusion Criteria: Type 1 of diabetes Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months Congestive Heart Failure (III or NYHA class IV) Liver disease such as cirrhosis or Chronic Active Hepatitis History of Lacticacidemia Use of any Oral Anti-diabetic Drug other than Metformin within the 2 months Use of insulin before screening visit ALT or AST >3 times the upper limit of Normal range Creatinine >1.5 mg/dl Other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Galvus group<br>the combination of metformin plus Vildagliptin: vildagliptin 50 mg bid plus metformin 1500mg Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy. | Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)<br>* vildagliptin 50 mg bid plus metformin 1500mg<br>|
| Active Comparator: Diabex group<br>metformin alone arm: metformin 1500mg plus metformin 500mg or 1000mg Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy | Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)<br>* metformin 1500mg plus metformin 500mg or 1000mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c at 24 weeks |  | 32weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c at 12 weeks |  | 32weeks | 
| Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week |  | 32weeks | 
| 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week |  | 32weeks | 
| Fasting Lipid profiles at 24 week |  | 32weeks | 
| Body weight at 24 week |  | 32weeks | 
| Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit |  | 32weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Galvus