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To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HRS9531 injection dose level 1 |
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| Treatment group B | Experimental | HRS9531 injection dose level 2 |
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| Treatment group C | Experimental | HRS9531 injection dose level 3 |
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| Treatment group D | Experimental | HRS9531 injection dose level 4 |
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| Treatment group E | Placebo Comparator | HRS9531 injection Placebo dose level 1 |
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| Treatment group F | Placebo Comparator | HRS9531 injection Placebo dose level 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c after 20 weeks of treatment | Week 0 to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment | Week 0 to Week 20 | |
| Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment | Week 0 to Week 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | 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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A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
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| Treatment group G | Placebo Comparator | HRS9531 injection Placebo dose level 3 |
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| Treatment group H | Placebo Comparator | HRS9531 injection Placebo dose level 4 |
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| HRS9531 injection Placebo | Drug | single dose |
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| Change From Baseline in HbA1c after 32 weeks | Week 0 to Week 32 |
| Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment | Week 0 to Week 20 |
| Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment | Week 0 to Week 32 |
| Change from baseline body Weight and waist circumference after 20 weeks of treatment | Week 0 to Week 20 |
| Change from baseline in body Weight and waist circumference after 32 weeks of treatment | Week 0 to Week 32 |
| Number of Participants With Anti-HRS9531 Antibody | Week 0 to Week 36 |
| Number of AEs During the Trial | Week 0 to Week 36 |
| D004700 | Endocrine System Diseases |