Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Official Title
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A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Comparator: Sitagliptin
* Drug: Comparator: Placebo
* Drug: Comparator: Pioglitazone
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has type 2 diabetes mellitus (T2DM) Patient is 18 years of age (or older) Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period Exclusion Criteria: Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis Patient required insulin within the prior 8 weeks Patient is on a weight loss program and is not in the maintenance phase Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate) Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis) Patient has any of the following disorders within the past 6 months: Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder. Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months Patient has severe peripheral vascular disease Patient has congestive heart failure Patient is HIV positive Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) Patient has a history of neoplastic disease Patient has a history of alcohol or drug abuse within the past 3 years Patient has viral hepatitis (hepatitis B or C)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin 100 mg<br>Sitagliptin 100 mg | Drug: Comparator: Sitagliptin<br>* Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24<br>* Other names: Januvia;Drug: Comparator: Pioglitazone<br>* Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8<br>* Other names: ACTOS;Drug: Metformin<br>* Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Comparator: Placebo<br>* Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24<br>Drug: Comparator: Pioglitazone<br>* Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8<br>* Other names: ACTOS;Drug: Metformin<br>* Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and week 24 |