Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20094 5mg | Experimental |
| |
| HS-20094 10mg | Experimental |
| |
| HS-20094 15mg | Experimental |
| |
| Dulaglutide 1.5mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20094 | Drug | Administrated by subcutaneous injection once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of HbA1c in the patients | From baseline to week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients reaching the HbA1c target of ≤ 6.5% | From baseline to week 32 | |
| The percentage of patients reaching the HbA1c target of<7.0% | From baseline to week 32 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital) | Tianjin | Tianjin Municipality | China |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dulaglutide | Drug | Administrated by subcutaneous injection once a week |
|
| Palcebo | Drug | Administrated by subcutaneous injection once a week |
|
| The change in fasting blood glucose |
| From baseline to week 32 |
| The change in C peptide | From baseline to week 32 |
| The change of fasting insulin in the patients | From baseline to week 32 |
| The change in body weight | From baseline to week 32 |
| The percentage of patients with 5% or greater body weight loss | From baseline to week 32 |
| D004700 | Endocrine System Diseases |