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| ID | Type | Description | Link |
|---|---|---|---|
| Japic CTI-111668 | Registry Identifier | Japan Pharmaceutical Information Center |
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| Name | Class |
|---|---|
| MSD K.K. | UNKNOWN |
This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental |
| |
| P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0431/ONO-5435 | Drug | Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability | 12 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | 12 weeks | |
| 2-hour postmeal glucose | 12 weeks | |
| Fasting plasma glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akiteru Seki | First Division Clinical Development Planning 1 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku Region Clinical Site | Chugoku | Japan | ||||
| Chubu Region Clinical Site |
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| Placebo, MK-0431/ONO-5435 | Drug | Double-blind period (12 wks); placebo QD. The double-blind period will be followed by a 40 wk open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD. |
|
| 12 weeks |
| Chūbu |
| Japan |
| Kanto Region Clinical Site | Kanto | Japan |
| Kinki Region Clinical Site | Kinki | Japan |
| Kyusyu Region Clinical Site | Kyusyu | Japan |
| Tohoku Region Clinical Site | Tōhoku | Japan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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