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Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - INCB013739 & Metformin | Experimental | INCB013739 5 mg QD and Metformin |
|
| Treatment B - INCB013739 & Metformin | Experimental | INCB013739 15 mg QD and Metformin |
|
| Treatment C - INCB013739 & Metformin | Experimental | INCB013739 50 mg QD and Metformin |
|
| Treatment D - INCB013739 & Metformin | Experimental | INCB013739 100 mg QD and Metformin |
|
| Treatment E - INCB013739 & Metformin | Experimental | INCB013739 200 mg QD and Metformin |
|
| Treatment F - Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB013739 | Drug | INCB013739 5 mg QD tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) | Baseline and Week 12 (or early termination study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 12 in fasting plasma glucose (FPG). | Baseline and Week 12 (or early termination study visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bill Williams, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35242 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20413513 | Derived | Rosenstock J, Banarer S, Fonseca VA, Inzucchi SE, Sun W, Yao W, Hollis G, Flores R, Levy R, Williams WV, Seckl JR, Huber R; INCB13739-202 Principal Investigators. The 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor INCB13739 improves hyperglycemia in patients with type 2 diabetes inadequately controlled by metformin monotherapy. Diabetes Care. 2010 Jul;33(7):1516-22. doi: 10.2337/dc09-2315. Epub 2010 Apr 22. |
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Matching placebo
|
| INCB013739 |
| Drug |
INCB013739 15 mg QD tablet |
|
| INCB013739 | Drug | INCB013739 50 mg QD tablet |
|
| INCB013739 | Drug | INCB013739 100 mg QD tablet |
|
| INCB013739 | Drug | INCB013739 200 mg QD |
|
| Placebo comparator matching INCB013739 | Drug | Orally once daily tablet |
|
| Metformin | Drug |
|
| Artesia |
| California |
| United States |
| Calabasas | California | 91307 | United States |
| Fresno | California | 93720 | United States |
| Los Angeles | California | 90057 | United States |
| Los Gatos | California | 95032 | United States |
| Santa Ana | California | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Chiefland | Florida | 32626 | United States |
| Hollywood | Florida | 33021 | United States |
| Longwood | Florida | 32779 | United States |
| Miami | Florida | 33126 | United States |
| Miami Beach | Florida | 33140 | United States |
| Ocala | Florida | 34471 | United States |
| Orlando | Florida | 32806 | United States |
| South Miami | Florida | 33143 | United States |
| Tampa | Florida | 33614 | United States |
| Dunwoody | Georgia | 30338 | United States |
| Rome | Georgia | 30165 | United States |
| Belleville | Illinois | 62220 | United States |
| Shawnee Mission | Kansas | 66216 | United States |
| Bangor | Maine | 04401 | United States |
| Columbia | Maryland | 21045 | United States |
| Sterling Heights | Michigan | 48314 | United States |
| Florissant | Missouri | 63031 | United States |
| St Louis | Missouri | 63128 | United States |
| St Louis | Missouri | 63141 | United States |
| Las Vegas | Nevada | 89101 | United States |
| New York | New York | 10016 | United States |
| Springfield Gardens | New York | 11413 | United States |
| West Seneca | New York | 14224 | United States |
| Calabash | North Carolina | 95032 | United States |
| Mooresville | North Carolina | 28117 | United States |
| New Bern | North Carolina | 28562 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Kettering | Ohio | 45429 | United States |
| Norton | Ohio | 44614 | United States |
| Norman | Oklahoma | 73071 | United States |
| Altoona | Pennsylvania | 16601 | United States |
| Harleysville | Pennsylvania | 19438 | United States |
| Jenkintown | Pennsylvania | 19046 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Greenville | South Carolina | 29615 | United States |
| North Myrtle Beach | South Carolina | 29582 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Bristol | Tennessee | 37620 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75230 | United States |
| Georgetown | Texas | United States |
| Houston | Texas | 77004 | United States |
| Houston | Texas | 77023 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77081 | United States |
| Houston | Texas | 77090 | United States |
| Midland | Texas | 79705 | United States |
| North Richland Hills | Texas | 76180 | United States |
| San Antonio | Texas | 78229 | United States |
| Temple | Texas | 76502 | United States |
| Waco | Texas | 76710 | United States |
| Burke | Virginia | 22015 | United States |
| Hampton | Virginia | 23666 | United States |
| Milwaukee | Wisconsin | 53209 | United States |
| Carolina | 00983 | Puerto Rico |
| Fajardo | 00738 | Puerto Rico |
| Ponce | 00716 | Puerto Rico |
| Rio Grande | 00745 | Puerto Rico |
| San Juan | 00909-1711 | Puerto Rico |
| San Juan | 00926-2832 | Puerto Rico |
| 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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