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The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HR17031 injection | Experimental |
| |
| Treatment group B: insulin glargine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR17031 injection | Drug | HR17031 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c: Changes in HbA1c from baseline to week 26 | 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 after 26 weeks of treatment | 26 weeks | |
| Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | 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 |
|
| week 26 |
| Actual Daily Insulin dose at week 26 | week 26 |
| Proportion of subjects achieved HbA1c≤6.5% at week 26 | week 26 |
| Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment | 26 weeks |
| Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26 | week 26 |
| Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment | 12weeks |
| Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment | 12weeks |
| Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26 | at week 26 |
| Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26 | at week 26 |
| Proportion of subjects achieved HbA1c<5.7% at week 26 | at week 26 |
| Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26; | week 26; |
| Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment | 26 weeks |
| Changes in HbA1c from baseline after 52 weeks of treatment | 52 weeks |
| Changes in FBG from baseline after 52 weeks of treatment | 52 weeks |
| Changes in body weight from baseline after 52 weeks of treatment | 52 weeks |
| Proportion of subjects achieved HbA1c<7% at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c≤6.5% at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<7% without body weight gain at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<5.7% at week 52 | at week 52 |
| Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52 | week 52 |
| Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment | 52 weeks |
| Actual Daily Insulin dose at week 52 | at week 52 |
| Number of Treatment-emergent Hypoglycemic event from screening to week 53 | from screening to week 53 |
| Number of Treatment-emergent Adverse Events from screening to week 53 | from screening to week 53 |
| Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27 | at week 27 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |