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This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR4 Injection | Experimental | GZR4 Injection + Oral Antidiabetic Drug |
|
| Insulin Degludec | Active Comparator | Insulin Degludec + Oral Antidiabetic Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR4 Injection | Drug | GZR4 injection s.c., once-weekly, treat-to-target dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in HbA1c after 16 weeks of treatment | From baseline (week 0) to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose(FPG) | Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment | From baseline (week 0) to week 16 |
| Weekly doses of GZR4 Injection/Insulin Degludec |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunyue Hao | Gan & Lee Pharmaceuticals. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 07 | Wuhan | Hubei | China | |||
| Study Site 06 |
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| Insulin Degludec |
| Drug |
Insulin Degludec s.c., once-daily, treat-to-target dose |
|
Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented.
| Week 15-16 |
| Incidence and Rate of Treatment-emergent adverse events (TEAEs) | A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period. | From baseline (week 0) to week 20 |
| Incidence and Rate of hypoglycemia episodes | Hypoglycaemia alert episodes (level 1) are defined as episodes that are sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by blood glucose (BG) meter. Clinically significant hypoglycaemic episodes (level 2) are defined as episodes that are sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) are defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) are defined as episodes that are associated with severe cognitive impairment requiring external assistance for recovery. | From baseline (week 0) to week 20 |
| Change in ADA of GZR4 | Blood samples will be analysed for anti-GZR4 antibodies | From baseline (week 0) to week 16 |
| Change in Nab of GZR4 | Blood samples will be analysed for Nab | From baseline (week 0) to week 16 |
| Changzhou |
| Jiangsu |
| China |
| Study Site 08 | Jinan | Shandong | China |
| Study Site 04 | Zibo | Shandong | China |
| Study Site 03 | Xi’an | Shanxi | China |
| Study Site 02 | Beijing | China |
| Study Site 05 | Beijing | China |
| Study Site 01 | Tianjin | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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