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Study ended after diabetes development plan review. .
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Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 5 mg of INCB019602 in AM with placebo administration in PM |
|
| Treatment B | Experimental | 20 mg of INCB019602 in AM with placebo administration in PM |
|
| Treatment C | Experimental | 5 mg of INCB019602 in PM with placebo administration in AM |
|
| Treatment D | Experimental | 20 mg of INCB019602 in PM with placebo administration in AM |
|
| Treatment E | Experimental | 7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days |
|
| Treatment F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB019602 | Drug | 5 mg of INCB019602 in AM with placebo administration in PM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters. | End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients. | End of Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William V Williams, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85029 | United States | |||
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| Placebo Comparator |
Placebo BID |
|
| INCB019602 |
| Drug |
20 mg in AM with placebo administration in PM |
|
| INCB019602 | Drug | 5 mg in PM with placebo administration in AM |
|
| INCB019602 | Drug | 20 mg in PM with placebo administration in AM |
|
| INCB019602 | Drug | 7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days |
|
| Placebo | Drug | Placebo administration in AM or PM depending on treatment arm dosing regimen. |
|
| Metformin | Drug | Stable dose metformin monotherapy |
|
| Tucson |
| Arizona |
| 85705 |
| United States |
| Chula Vista | California | 91911 | United States |
| Los Angeles | California | United States |
| Mission Viejo | California | 92691 | United States |
| Orange | California | 92869 | United States |
| Paramount | California | 90723 | United States |
| San Diego | California | 92117 | United States |
| Santa Ana | California | 92701 | United States |
| Tustin | California | 92780 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Shawnee Mission | Kansas | 66216 | United States |
| Shreveport | Louisiana | 71101 | United States |
| Dearborn | Michigan | 48126 | United States |
| St Louis | Missouri | 63110 | United States |
| Omaha | Nebraska | 68154 | United States |
| Elizabeth | New Jersey | 07202 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| East Providence | Rhode Island | 02914 | United States |
| San Antonio | Texas | 78229 | 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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