Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.

Official Title
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Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: pioglitazone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood glucose criteria must be met Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone Body mass index (BMI) in the range 22-45 Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Evidence of serious cardiovascular complications Evidence of serious diabetic complications Laboratory value abnormalities as defined by the protocol Known sensitivity to pioglitazone Other protocol-defined exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin 50 mg qd + pioglitazone 45 mg qd<br>Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks | Drug: Vildagliptin<br>* Vildagliptin 50 mg tablets<br>* Other names: Galvus;Drug: pioglitazone<br>* pioglitazone 45 mg qd<br>|
| Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd<br>Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks | Drug: Vildagliptin<br>* Vildagliptin 50 mg tablets<br>* Other names: Galvus;Drug: pioglitazone<br>* pioglitazone 45 mg qd<br>|
| Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd<br>Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks | Drug: pioglitazone<br>* pioglitazone 45 mg qd<br>Drug: Placebo<br>* Vildagliptin matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 24 weeks |  |  | 
| Patients with endpoint HbA1c <7% after 24 weeks |  |  | 
| Patients with reduction in HbA1c >/= to 0.7% after 24 weeks |  |  | 
| Adverse event profile after 24 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c |  |  | 

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