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The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.
A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.
Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3824+Metformin, Placebo+Metformin | Experimental | once daily for SHR3824 and placebo, three times daily for metformin, 24 weeks |
|
| SHR3824 5 mg+Metformin | Experimental | once daily for SHR3824, three times daily for metformin, 52 weeks |
|
| SHR3824 10 mg+Metformin | Experimental | once daily for SHR3824, three times daily for metformin, 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily, 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in HbA1c Levels | Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Fasting Plasma Glucose | Compared with the placebo with metformin group, mean change in Fasting Plasma Glucose Levels in SHR3824 with metformin group | Baseline to Week 24 |
| The number of volunteers with adverse events as a measurement of safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WENG Jianping, professor | Contact | 86-020-85250217 | wjianp@mail.sysu.edu.cn | |
| CHEN Jianwen, professor | Contact | 18036611985 | chenjianwen@hrglobe.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat - sen University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| SHR3824 |
| Drug |
Once daily, 52 weeks |
|
| metformin | Drug | Three times daily, 52 weeks |
|
Compared with the placebo with metformin group, the incidence of adverse events in SHR3824 with metformin group |
| Baseline to Week 52 |
| D004700 | Endocrine System Diseases |