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The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS9531-low dose | Experimental |
| |
| Treatment group B: HRS9531-high dose | Experimental |
| |
| Treatment group C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | HRS9531-low dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c after 40 weeks of treatment. | from baseline to Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reaching HbA1<7.0% | Proportion of subjects reaching HbA1<7.0% after 40 weeks of treatment. | from baseline to Week 40 |
| Proportion of subjects reaching HbA1≤6.5% | Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Chen | Contact | +86-0518-82342973 | hong.chen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perking University Peoples' Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | 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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| HRS9531 |
| Drug |
HRS9531-high dose |
|
| Placebo | Drug | Placebo |
|
| from baseline to Week 40 |
| Change in FPG | Change in FPG after 40 weeks of treatment. | from baseline to Week 40 |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score | Change from baseline in DTSQs after 40 weeks of treatment. | From baseline to Week 40 |
| D004700 | Endocrine System Diseases |