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The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P | Placebo Comparator |
| |
| E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Double-blind period (12 wk); 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 QD to 100 mg QD |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | 12 weeks | |
| safety | 52 weeks | |
| tolerability | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikio Nishii | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku Region | Chugoku | Japan | ||||
| Chubu Region |
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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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sitagliptin phosphate | Drug | Double-blind period (12 wk); 50 mg 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 QD to 100 mg QD |
|
| Chūbu |
| Japan |
| Hokkaido Region | Hokkaido | Japan |
| Kanto Region | Kanto | Japan |
| Kinki Region | Kinki | Japan |
| Kyushu Region | Kyushu | Japan |
| Shikoku Region | Shikoku | Japan |
| Tohoku Region | Tōhoku | Japan |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |