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The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3167 group A | Experimental |
| |
| SHR-3167 group B | Experimental |
| |
| Insulin glargine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3167 | Drug | Dose level 1. |
| |
| SHR-3167 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 20 in HbA1c (HemoglobinA1c) | Change from baseline in HbA1c after 20 weeks of treatment. | Week 0 to week 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving HbA1c<7.0% | Week 0 to week 20. | |
| Change from baseline to week 20 in fasting plasma glucose (FPG) | Week 0 to week 20. | |
| Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | 210029 | China | ||
| Shanghai Sixth People's Hospital |
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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 |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Dose level 2. |
|
| Insulin glargine | Drug | Dose level 3. |
|
| Week 0 to week 20. |
| Number of adverse events (AEs) during the trial | Week 0 to week 24. |
| Shanghai |
| Shanghai Municipality |
| 200233 |
| China |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |