Type 2 Diabetes
Conditions
Brief summary
The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.
Interventions
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HR17031 injection compared with Ins068 injection and SHR20004 injection
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18-70 age years, both inclusive; 2. BMI is 20.0 to 40.0 kg/m2, both inclusive; 3. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 4. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis; 5. At screening: 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
1. Use of systemic glucocorticoids within 3 months prior to the screening; 2. Use of weight loss drugs within 3 months prior to the screening. 3. Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes); 4. Laboratory findings at the screening visit: * Amylase and/or lipase \>3 x upper limit of normal (ULN); * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 x ULN; * Moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin; * Urinary albumin creatinine ratio (UACR) ≥300 mg/g; * Total bilirubin \>2.0 x ULN; * Calcitonin ≥50 ng/L; 5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)； 6. 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; 7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg); 8. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 9. History of pancreatitis (acute or chronic); 10. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in HbA1c at Week 26 | at Week 26 |
Secondary
| Measure | 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 | at Week 26 |
| Mean Actual Daily Insulin Dose at Week 26 | at Week 26 |
| Number of Hypoglycaemic Episodes at Week 26 | at Week 26 |
Countries
China
Outcome results
None listed