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This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 oral tablets formulation in participants with Type 2 Diabetes Mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC30 tablets Dose 1 | Experimental | Participants will receive ASC30 tablets Dose 1 administered orally once daily. |
|
| ASC30 tablets Dose 2 | Experimental | Participants will receive ASC30 tablets Dose 2 administered orally once daily. |
|
| ASC30 tablets Dose 3 | Experimental | Participants will receive ASC30 tablets Dose 3 administered orally once daily. |
|
| Placebo | Placebo Comparator | Participants will receive Placebo administered orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC30 tablets | Drug | ASC30 tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group | Baseline and end of Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group | Baseline and end of Week 13 | |
| Mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascletis Clinical Site | Riverside | California | 92506 | United States | ||
| Ascletis Clinical Site |
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| Placebo | Drug | Placebo administered orally once daily |
|
| Baseline and end of Week 13 |
| San Jose |
| California |
| 95128 |
| United States |
| Ascletis Clinical Site | Denver | Colorado | 80246 | United States |
| Ascletis Clinical Site | Miami | Florida | 33143 | United States |
| Ascletis Clinical Site | Miami | Florida | 33172 | United States |
| Ascletis Clinical Site | Decatur | Georgia | 30030 | United States |
| Ascletis Clinical Site | Springfield | Missouri | 65802 | United States |
| Ascletis Clinical Site | San Antonio | Texas | 78240 | 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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