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The purpose of this study is to compare the safety and effect of TTP054 versus placebo on glucose control in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTP054 400 mg | Experimental |
| |
| TTP054 200 mg | Experimental |
| |
| TTP054 800 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTP054 | Drug | Administered orally once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c (%) as compared to placebo | Day 1 to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose (mg/dL) | Day 1, Day 14, Day 28, Day 56 and Day 84 | |
| Subject achievement of HbA1c <7% | Day 84 | |
| Change from baseline in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Gustavson, Ph.D. | TransTech Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 18 | Chula Vista | California | 91911 | United States | ||
| Site 1 |
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| Placebo | Drug | Administered orally once daily for 12 weeks. |
|
| Day 1, Day 14, Day 28, Day 56 and Day 84 |
| Subject achievement of body weight loss ≥ 2% | Day 1 and Day 84 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Site 13 | Denver | Colorado | 80220 | United States |
| Site 4 | Coral Gables | Florida | 33134 | United States |
| Site 5 | Port Orange | Florida | 32127 | United States |
| Site 3 | Honolulu | Hawaii | 96814 | United States |
| Site 17 | Indianapolis | Indiana | 46254 | United States |
| Site 7 | Louisville | Kentucky | 40213 | United States |
| Site 8 | Auburn | Maine | 04210 | United States |
| Site 9 | Las Vegas | Nevada | 89101 | United States |
| Site 26 | Trenton | New Jersey | 08611 | United States |
| Site 12 | Rochester | New York | 14609 | United States |
| Site 14 | Cincinnati | Ohio | 45219 | United States |
| Site 6 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site 16 | Dallas | Texas | 75230 | United States |
| Site 10 | Houston | Texas | 77072 | United States |
| Site 2 | Houston | Texas | 77074 | United States |
| Site 11 | Katy | Texas | 77450 | United States |
| Site 15 | Richmond | Virginia | 23294 | 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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