Status:
UNKNOWN
A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Male or female, 18-70 age years, both inclusive;
- BMI is 20.0 to 40.0 kg/m2, both inclusive;
- Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
- 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
- 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:
- 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;
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；
- 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 measures；
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT05333835
Start Date
July 8 2022
End Date
March 30 2024
Last Update
April 25 2023
Active Locations (1)
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1
Peking university People's Hospital
Beijing, Beijing Municipality, China, 100044