A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: SHR20004 injection; Drug: HR17031 injection; Drug: INS068 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05333835

HR17031-201

Details and patient eligibility

About

The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.

Enrollment: 455 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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455 participants in 3 patient groups

HR17031 injection

Experimental group

Treatment:

Drug: HR17031 injection

INS068 injection

Active Comparator group

Treatment:

Drug: INS068 injection

SHR20004 injection

Active Comparator group

Treatment:

Drug: SHR20004 injection