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The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SK-0403 100 mg QD | Experimental |
| |
| SK-0403 200 mg QD | Experimental |
| |
| SK-0403 400 mg QD | Experimental |
| |
| SK-0403 200 mg BID | Experimental |
| |
| Placebo | Sham Comparator |
| |
| Sitagliptin 100 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SK-0403 | Drug | SK-0403 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline to Week 16. | Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF). | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fasting Plasma Glucose (FPG) | Baseline, 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Placebo | Drug | Placebo |
|
| Sitagliptin | Drug | Sitagliptin |
|
| Huntsville |
| Alabama |
| United States |
| Muscle Shoals | Alabama | United States |
| Phoenix | Arizona | United States |
| Encinitas | California | United States |
| Huntington Park | California | United States |
| Los Angeles | California | United States |
| San Mateo | California | United States |
| Spring Valley | California | United States |
| Walnut Creek | California | United States |
| Miami | Florida | United States |
| Palm Harbour | Florida | United States |
| Pembroke Pines | Florida | United States |
| Honolulu | Hawaii | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Lexington | Kentucky | United States |
| Paducah | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Saint Paul | Minnesota | United States |
| Charlotte | North Carolina | United States |
| Greenville | North Carolina | United States |
| Statesville | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Marion | Ohio | United States |
| Mount Giliad | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Eugene | Oregon | United States |
| Portland | Oregon | United States |
| Beaver | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Greensboro | South Carolina | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Sandy City | Utah | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| 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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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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