Efficacy and Long-Term 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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This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Metformin
* Drug: Placebo
* Drug: Sitagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18-78 years old inclusive at Visit 1 T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1 Patient agreement to maintain same dose of metformin throughout study HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1 Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1 Exclusion Criteria: Pregnant or nursing (lactating) women FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin Dose 1<br> | Drug: Vildagliptin<br> <br> Drug: Metformin<br> <br> |
| Experimental: Vildagliptin Dose 2<br> | Drug: Vildagliptin<br> <br> Drug: Metformin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Metformin<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Sitagliptin<br> | Drug: Metformin<br> <br> Drug: Sitagliptin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment. |  | 24 weeks | 
| To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment. |  | 24 weeks | 
| To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin. |  | 24 weeks | 
| To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. |  | 24 weeks | 
| To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM. |  | 76 weeks | 
| To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. |  | 24 weeks | 
| To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM. |  | 76 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, vildagliptin