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To compare the efficacy and safety of HR17031 injection and insulin glargine, including the changes of efficacy indicators such as HbA1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HR17031 injection | Experimental |
| |
| Treatment group B: insulin glargine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR17031 injection | Drug | HR17031 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c from baseline to week 26 | from baseline to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieved HbA1c<7.0% at week 26 | at week 26 | |
| Change in body weight from baseline to week 26 | from baseline to week 26 | |
| Proportion of subjects achieved HbA1c<7.0% and no weight gain at week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University | Tianjin | Tianjin Municipality | 300400 | China |
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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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| insulin glargine |
| Drug |
insulin glargine |
|
| at week 26 |
| Daily Insulin dose at week 26 | at week 26 |
| The proportion of subjects achieved HbA1c≤6.5% at week 26 | at week 26 |
| Changes in FPG from baseline to week 26 | from baseline to week 26 |
| Hypoglycemic event from screening to week 27 | from screening to week 27 |
| Adverse events from screening to week 27 | from screening to week 27 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |