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This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 6.0mg | Experimental | ①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks;③6mg, SC, once a week* 20weeks. |
|
| dulaglutide | Experimental | 1.5mg, SC, once a week* 28weeks |
|
| IBI362 4.0mg | Experimental | 2mg, SC, once a week* 4weeks; â‘¡4mg, SC, once a week* 24weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dulaglutide | Drug | Dulaglutide administered subcutaneously (SC) once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change from baseline at week 28 | Baseline, 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| percent change from baseline in body weigh | Baseline, 28 weeks | |
| Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline | Baseline, 28 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijin | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41407860 | Derived | Guo L, Zhang B, Xue X, Zhang X, Cai H, Jiang H, Zhang L, Jin P, Wang X, Cheng Z, Zhang S, Geng J, Guo Y, Hu H, Ma Q, Li L, Du H, Han-Zhang H, Xue F, Deng H, Qian L, Yang W; DREAMS-2 investigators. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature. 2026 Apr;652(8108):181-188. doi: 10.1038/s41586-025-10031-z. Epub 2025 Dec 17. |
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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 |
|---|---|
| C555680 | dulaglutide |
| C000719829 | mazdutide |
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| IBI362 |
| Drug |
IBI362 administered subcutaneously (SC) once a week. |
|
| Change from baseline in HbA1c (superiority) |
| Baseline, 28 weeks |
| Proportion of subjects with HbA1c <7.0% | Baseline, 28 weeks |
| Safety,Incidence and severity of adverse events and correlation with study drug; | Baseline to 32weeks |
| Time to peak plasma concentration (Tmax) | Baseline to 28weeks |
| Time to peak plasma concentration (Cmax) | Baseline to 28weeks |
| area under curve (AUC) | Baseline to 28weeks |
| volume distribution (V) | Baseline to 28weeks |
| half-life (half-life, T1/2 | Baseline to 28weeks |
| clearance rate (clearance, CL) | Baseline to 28weeks |
| To assess changes in PD parameters fasting insulin at different time points before and after administration. | Baseline to 28weeks |
| To assess changes in PD parameters fasting C-peptide at different time points before and after administration. | Baseline to 28weeks |
| D004700 | Endocrine System Diseases |