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The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR17031 injection | Experimental |
| |
| INS068 injection | Active Comparator |
| |
| SHR20004 injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR17031 injection | Drug | HR17031 injection |
| |
| INS068 injection |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in HbA1c at Week 26 | at Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26 | at Week 26 | |
| Mean Change From Baseline in Body Weight at Week 26 | at Week 26 | |
| Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26 |
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Inclusion Criteria:
1) Treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose [MTD, ≥1000 mg]) for ≥3 months, or 2) Treatment with metformin at the above dose level combined with a second OAD (AGI, SU, TZD, glinides, DPP-4i or SGLT2i) on a stable dose (≥half of the max approved dose according to local label, or at the MTD) for ≥3 months.
Exclusion Criteria:
Use of systemic glucocorticoids within 3 months prior to the screening;
Use of weight loss drugs within 3 months prior to the screening.
Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes);
Laboratory findings at the screening visit:
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)ï¼›
Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures;
Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
History of pancreatitis (acute or chronic);
Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measuresï¼›
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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HR17031 injection compared with Ins068 injection and SHR20004 injection
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| Drug |
INS068 injection |
|
| SHR20004 injection | Drug | SHR20004 injection |
|
| at Week 26 |
| Mean Actual Daily Insulin Dose at Week 26 | at Week 26 |
| Number of Hypoglycaemic Episodes at Week 26 | at Week 26 |
| 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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