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This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM.
Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEC88473 dose1 | Experimental | T2DM subjects, receiving a weekly dose of HEC88473 dose1 |
|
| HEC88473 dose2 | Experimental | T2DM subjects, receiving a weekly dose of HEC88473 dose2 |
|
| HEC88473 dose3 | Experimental | T2DM subjects, receiving a weekly dose of HEC88473 dose3 |
|
| Placebo | Placebo Comparator | T2DM subjects, receiving a weekly dose of placebo |
|
| Dulaglutide | Active Comparator | T2DM subjects, receiving a weekly dose of dulaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC88473, Placebo, Dulaglutide | Drug | T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of HbA1c at week 12 | HbA1c | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of weight at week 12 | weight | Baseline to week 12 |
| Change from baseline of fasting blood-glucose at week 12 | fasting blood-glucose |
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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 | ||
| Shijiazhuang People's Hospital |
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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 |
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| Baseline to week 12 |
| Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline to week 15 |
| Shijiazhuang |
| Hebei |
| 050000 |
| China |
| D004700 | Endocrine System Diseases |