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This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR4 group | Experimental |
| |
| Insulin Glargine U100 group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR4 | Drug | GZR4 s.c., once-weekly,treat-to-target dose |
| |
| Insulin Glargine U100 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | From baseline (week 0) to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | From baseline (week 0) to week 52 | |
| hypoglycaemia events | From baseline (week 0) to week 26/52 | |
| adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals Shandong Co., Ltd. | Linyi | Shandong | 276000 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Drug |
Insulin Glargine U100 s.c.,once-daily,treat-to-target dose |
|
| From baseline (week 0) to week 26/52 |
| Change in weight | From baseline (week 0) to week 26 |
| D006946 | Hyperinsulinism |