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This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control.
The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period.
Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c<8.5% or HbA1c ≥ 8.5% before randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 4.0 mg | Experimental | â‘ 2mg, subcutaneously (SC), once a week* 4weeks; â‘¡4mg, SC, once a week* 44weeks. |
|
| IBI362 6.0 mg | Experimental | â‘ 2mg, SC, once a week* 4weeks; â‘¡4mg, SC, once a week* 4weeksï¼› â‘¢6mg, SC, once a week* 40weeks. |
|
| placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | placebo administered subcutaneously (SC) once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change from baseline at week 24 | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with HbA1c<7.0% at week 24 | Baseline, 24 weeks | |
| Safety, Incidence and severity of adverse events and correlation with study drug; | Baseline to 52 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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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 |
|---|---|
| C000719829 | mazdutide |
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| IBI362 |
| Drug |
IBI362 administered subcutaneously (SC) once a week. |
|
| Time to peak plasma concentration (Tmax) |
| Baseline to 52 weeks |
| Time to peak plasma concentration (Cmax) | Baseline to 52 weeks |
| area under curve (AUC) | Baseline to 52 weeks |
| volume distribution (V) | Baseline to 52 weeks |
| half-life (half-life, T1/2) | Baseline to 52 weeks |
| clearance rate (clearance, CL) | Baseline to 52 weeks |
| To assess changes in PD parameters fasting insulin at different time points before and after administration. | Baseline to 52 weeks |
| To assess changes in PD parameters fasting C-peptide at different time points before and after administration. | Baseline to 52 weeks |
| D004700 | Endocrine System Diseases |