A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes

NCT ID: NCT06871761

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 393 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2025-05-13

Brief Summary

To compare the efficacy and safety of HR17031 injection and insulin glargine, including the changes of efficacy indicators such as HbA1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.

Conditions

Adult Patients With Type 2 Diabetes

Study Design

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

Study Groups

Treatment group A: HR17031 injection

Group Type: EXPERIMENTAL

HR17031 injection

Intervention Type: DRUG

HR17031 injection

Treatment group B: insulin glargine

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

insulin glargine

Interventions

HR17031 injection

HR17031 injection

Intervention Type: DRUG

insulin glargine

insulin glargine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged 18-75 years at the time of signing the informed consent (both ends included)

2. Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included)

3. Diagnosed with type 2 diabetes for at least 90 days prior to screening

4. Tested by local laboratory, HbA1c is 7.5%-10.5% (including both ends)

5. Before screening, the daily basal insulin dose had been stabilized at 20-40U/ day (including both ends) for at least 60 days

6. Stable treatment with metformin alone or in combination with another OAD for ≥60 days prior to screening. Metformin dose ≥1500 mg/ day or maximum tolerated dose.

7. Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.

Exclusion Criteria

1. Known or suspected allergy to the investigational drug product or its components or excipients;

2. Systemic glucocorticoid use within 3 months prior to screening

3. Use of weight loss drugs within 3 months prior to screening

4. Insulin therapy other than basal insulin was used within 3 months prior to screening

5. Cardiovascular disease, defined as congestive heart failure (NYHA III-IV), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; And/or coronary, carotid, or peripheral arterial revascularization is planned at screening

6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)

7. Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;

8. Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;

9. Known or suspected abuse of alcohol or narcotics;

10. Previous history of pancreatitis (acute or chronic)

11. During pregnancy or lactation;fertile women (WOCBP) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product;

12. Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

HR17031-302

Identifier Type: -

Identifier Source: org_study_id