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The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 0.5 mg rivoglitazone HCl tablets once daily for 12 weeks |
|
| 2 | Experimental | 1.0 mg rivoglitazone HCl tablets once daily for 12 weeks |
|
| 3 | Experimental | 1.5 mg rivoglitazone HCl tablets once daily for 12 weeks |
|
| 4 | Active Comparator | 30 mg pioglitazone HCl capsules once daily for 12 weeks |
|
| 5 | Placebo Comparator | Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivoglitazone HCl | Drug | 0.5 mg rivoglitazone HCl tablets once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | China |
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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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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| rivoglitazone HCl |
| Drug |
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks |
|
| rivoglitazone HCl | Drug | 1.5 mg rivoglitazone HCl tablets once daily for 12 weeks |
|
| pioglitazone HCl | Drug | 30 mg capsules once daily for 12 weeks |
|
| placebo | Drug | matching tablets or capsule once daily for 12 weeks |
|
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |