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This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TT223 with Metformin and/or TZD | Experimental | TT223 as a treatment for Type 2 diabetes is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD). |
|
| Placebo with Metformin and/or TZD | Placebo Comparator | Placebo as a comparator is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT223 with Metformin and/or TZD | Drug | Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg. | For the duration of the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of TT223 as a treatment for Type 2 diabetes by comparing the change in HbA1c value from baseline between the TT223 and placebo groups. | For the duration of the trial. | |
| To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
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| Placebo with Metformin and/or TZD | Drug | Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks |
|
| For the duration of the trial. |
| To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients. | Day 1 and Week 12 of treatment. |
| Los Angeles |
| California |
| United States |
| Santa Ana | California | United States |
| Torrence | California | United States |
| Walnut Creek | California | United States |
| DeLand | Florida | United States |
| Bloomingdale | Illinois | United States |
| Grand Rapids | Michigan | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Clifton | New Jersey | United States |
| Asheboro | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Bensalem | Pennsylvania | United States |
| Athens | Tennessee | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Richmond | Texas | United States |
| San Antonio | Texas | 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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