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The objective of the study is to compare the efficacy and safety of 3 doses CS02 Tablet in combination with a stable dose of metformin monotherapy against CS02 PTM (placebo) Tablet in combination with a stable dose of metformin monotherapy over a 12 weeks treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose of CS02 | Experimental | Subjects will receive 450mg of CS02 combined with a stable dose of metformin monotherapy. |
|
| middle dose of CS02 | Experimental | Subjects will receive 300mg of CS02 combined with a stable dose of metformin monotherapy. |
|
| low dose of CS02 | Experimental | Subjects will receive 150mg of CS02 combined with a stable dose of metformin monotherapy. |
|
| placebo control | Placebo Comparator | Subjects will receive placebo combined with a stable dose of metformin monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS02 tablet and placebo tablet | Drug | Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The HbA1c treatment effect among CS02 groups and the Placebo group | To assess 208 evaluable subject of the change in HbA1c from baseline to end of treatment among CS02 groups and CS02 placebo to match group will be compared with the analysis of covariance model including baseline HbA1c as covariate, and treatment groups and regions as fixed effects. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Research Center of Arkansas, Inc. | Little Rock | Arkansas | 72212 | United States | ||
| Clinical Research of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35917580 | Derived | Wang CY, Huang KC, Lu CW, Chu CH, Huang CN, Chen HS, Lee IT, Chen JF, Chen CC, Chen CS, Hsieh CH, Tien KJ, Chien HY, Huang YY, Hsu JP, Shane GT, Chang AC, Wu YC, Sheu WH. A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):e4063-e4071. doi: 10.1210/clinem/dgac436. |
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| Coral Gables |
| Florida |
| 33134 |
| United States |
| The Community Research of South Florida | Hialeah | Florida | 33016 | United States |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Chi-Mei Medical Center | Tainan | 710 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Veterans general Hospital | Taipei | 11217 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Chang Gung Memorial Hospital_Linkou | Taoyuan | 333 | Taiwan |