Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)

Study Overview
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Brief Summary
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A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.

Official Title
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An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: MK0533
* Drug: Comparator: Placebo (unspecified)
* Drug: Comparator: pioglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened Exclusion Criteria: Patients taking any medicines that affect body fluid level such as a diuretic or water pill Patients taking niacin or other certain medications Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Part1 - Arm 1<br>Part1: Arm 1: drug | Drug: MK0533<br>* Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.<br>|
| Placebo Comparator: Part1 - Arm 2<br>Part1 - Arm 2: Pbo comparator | Drug: Comparator: Placebo (unspecified)<br>* MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.<br>|
| Placebo Comparator: Part 2 - Arm 1<br>Part 2 - Arm 1: Pbo | Drug: Comparator: Placebo (unspecified)<br>* MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.<br>|
| Experimental: Part 2 - Arm 2<br>Part 2- Arm 2: drug 5mg | Drug: MK0533<br>* Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.<br>|
| Experimental: Part 2 - Arm 3<br>Part 2 - Arm 3: drug 15mg | Drug: MK0533<br>* Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.<br>|
| Experimental: Part 2 - Arm 4<br>Part 2 - Arm 4: drug 30mg | Drug: MK0533<br>* Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.<br>|
| Active Comparator: Part 2 - Arm 5<br>Part 2 - Arm 5: active comparator | Drug: Comparator: pioglitazone<br>* pioglitazone 45mg. Study period is a total of 24 wks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fluid gain from baseline after 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose after 12 weeks |  | 12 weeks |