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

NCT ID: NCT05333835

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 455 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2024-03-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HR17031 injection

Group Type: EXPERIMENTAL

HR17031 injection

Intervention Type: DRUG

HR17031 injection

INS068 injection

Group Type: ACTIVE_COMPARATOR

INS068 injection

Intervention Type: DRUG

INS068 injection

SHR20004 injection

Group Type: ACTIVE_COMPARATOR

SHR20004 injection

Intervention Type: DRUG

SHR20004 injection

Interventions

HR17031 injection

HR17031 injection

Intervention Type: DRUG

INS068 injection

INS068 injection

Intervention Type: DRUG

SHR20004 injection

SHR20004 injection

Intervention Type: DRUG

Eligibility Criteria

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；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking university People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HR17031-201

Identifier Type: -

Identifier Source: org_study_id