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| ID | Type | Description | Link |
|---|---|---|---|
| MK0533-005 | |||
| 2007_544 |
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This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic & body fluid benefits vs. the comparitor
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A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1 - Arm 1 | Experimental | Part1: Arm 1: drug |
|
| Part1 - Arm 2 | Placebo Comparator | Part1 - Arm 2: Pbo comparator |
|
| Part 2 - Arm 1 | Placebo Comparator | Part 2 - Arm 1: Pbo |
|
| Part 2 - Arm 2 | Experimental | Part 2- Arm 2: drug 5mg |
|
| Part 2 - Arm 3 | Experimental | Part 2 - Arm 3: drug 15mg |
|
| Part 2 - Arm 4 | Experimental | Part 2 - Arm 4: drug 30mg |
|
| Part 2 - Arm 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0533 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body fluid gain from baseline after 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose after 12 weeks | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Active Comparator |
Part 2 - Arm 5: active comparator |
|
| Comparator: Placebo (unspecified) | Drug | MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks. |
|
| Comparator: pioglitazone | Drug | pioglitazone 45mg. Study period is a total of 24 wks. |
|
| D004700 | Endocrine System Diseases |