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This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group, Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight following administration for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTP273 300 mg daily (150 mg BID) | Experimental | Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks |
|
| TTP273 150 mg daily | Experimental | Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Two matching placebo tablets administered orally twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTP273 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline at 12 weeks | Day 1 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieve HbA1c <7% at 12 weeks | Day 1 to Week 12 | |
| Change in body weight from baseline at 12 weeks | Day 1 to Week 12 | |
| Change in plasma glucose levels from baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucagon levels from baseline at 12 weeks | Day 1 to Week 12 | |
| Change in glucagon-like peptide-1 levels from baseline at 12 weeks | Day 1 to Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Freeman, Ph.D. | vTv Therapeutics LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costa Mesa | California | 92626 | United States | |||
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| Drug |
|
| Day 1 to Week 12 |
| Change in lipid Levels from baseline at 12 weeks | Day 1 to Week 12 |
| Change in insulin levels from baseline at 12 weeks | Day 1 to Week 12 |
| Change in C-peptide levels from baseline at 12 weeks | Day 1 to Week 12 |
| Adverse Events | Day 1 to Week 14 |
| Blood Pressure | Day 1 to Week 14 |
| Electrocardiogram Parameters | Day 1 to Week 14 |
| Hematology | Day 1 to Week 14 |
| Blood Chemistry | Day 1 to Week 14 |
| Urinalysis | Day 1 to Week 14 |
| Pulse | Day 1 to Week 14 |
| Encino |
| California |
| 91436 |
| United States |
| Huntington Park | California | 90255 | United States |
| Los Angeles | California | 90057 | United States |
| Oakland | California | 94612 | United States |
| Sacramento | California | 95821 | United States |
| DeLand | Florida | 32720 | United States |
| Miami Lakes | Florida | 33014 | United States |
| Port Orange | Florida | 32129 | United States |
| Tampa | Florida | 33606 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Atlanta | Georgia | 30338 | United States |
| Evanston | Illinois | 60201 | United States |
| Flint | Michigan | 48504 | United States |
| Omaha | Nebraska | 68114 | United States |
| The Bronx | New York | 10459 | United States |
| Greensboro | North Carolina | 27408 | United States |
| High Point | North Carolina | 27265 | United States |
| Morehead City | North Carolina | 28557 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Norman | Oklahoma | 73069 | United States |
| Norman | Oklahoma | 73072 | United States |
| Corpus Christi | Texas | 78413 | United States |
| Houston | Texas | 77074 | United States |
| Humble | Texas | 77338 | United States |
| Hurst | Texas | 76054 | United States |
| Katy | Texas | 77450 | United States |
| San Antonio | Texas | 78209 | United States |
| San Antonio | Texas | 78229 | United States |
| Richland | Washington | 99352 | 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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