MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Study Overview
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Brief Summary
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A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Official Title
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A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: sitagliptin phosphate (+) metformin hydrochloride
* Drug: Comparator: pioglitazone


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Patient has type 2 diabetes mellitus Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: Patient has a history of type 1 diabetes mellitus or history of ketoacidosis Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sitagliptin phosphate (+) metformin hydrochloride | Drug: sitagliptin phosphate (+) metformin hydrochloride<br>* sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an  32 wk treatment period<br>* Other names: Janumet;|
| Active Comparator: 2<br>pioglitazone | Drug: Comparator: pioglitazone<br>* pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an  32-wk treatment period.<br>* Other names: pioglitazone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at Week 32 | A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent | Baseline and Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 | Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone | Baseline and Week 1 | 
| Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 | Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG | Baseline and Week 32 | 
| Change From Baseline in FPG at Week 32 | Change from baseline reflects the Week 32 FPG minus the baseline FPG | Baseline and Week 32 | 
| Percent of Participants With A1C <7.0% at Week 32 |  | Week 32 |