Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Official Title
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A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Conditions
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Type 2 Diabetes Mellitus

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has Type 2 diabetes Currently taking metformin >1500 mg/day for at least 10 weeks Male or female Exclusion Criteria: Patient has peripheral edema History of type 1 diabetes Patient required insulin within prior 8 weeks Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study Participating in a weight loss program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Sitagliptin<br>sitagliptin 100 mg | Drug: Sitagliptin<br>* Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.<br>* Other names: Januvia;Drug: Comparator: Metformin<br>* Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.<br>|
| Active Comparator: Rosiglitazone<br>rosiglitazone 8 mg | Drug: Comparator: Rosiglitazone<br>* Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.<br>* Other names: Avandia;Drug: Comparator: Metformin<br>* Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.<br>|
| Placebo Comparator: Placebo<br>placebo | Drug: Comparator: Placebo<br>* placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.<br>Drug: Comparator: Metformin<br>* Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C (A1C) at Week 18 | A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo. | Baseline and 18 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) at Week 18 | The change from baseline is the Week 18 FPG minus the Week 0 FPG. | Baseline and 18 Weeks | 
| 2-hour Post-meal Glucose (PMG) at Week 18 | The change from baseline is the Week 18 PMG minus the Week 0 PMG. | Baseline and 18 Weeks |