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The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with diabetic kidney disease in type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A,Subjects will receive Placebo administered orally | Placebo Comparator |
| |
| Group B,Subjects will receive HRS-7535 administered orally | Experimental |
| |
| Group C,Subjects will receive escalated HRS-7535 administered orally | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of UACR at week 16 to UACR at baseline | at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour urine analysis results at Week 16 | at Week 16 | |
| Proportion of subjects with a 30% decrease in UACR from baseline at Week 16 | at Week 16 | |
| Change from baseline in eGFR at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| HRS-7535 |
| Drug |
HRS-7535 |
|
| at Week 16 |
| Change from baseline in HbA1c at Week 16 | at Week 16 |
| Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16 | at Week 16 |
| Change from baseline in FPG at Week 16 | at Week 16 |
| Change from baseline in insulin at Week 16 | at Week 16 |
| Change from baseline in c-peptide at Week 16 | at Week 16 |
| Change from baseline in body weight at Week 16 | at Week 16 |
| Proportion of subjects receiving glycemic rescue medicine at Week 16 | at Week 16 |
| A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16 | at Week 16 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |