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

NCT ID: NCT06881264

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-09-19

Brief Summary

The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents

Conditions

Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs

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: EXPERIMENTAL

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%-11% (including both ends);

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

6. When screening: ① metformin monotherapy stable treatment ≥ 3 months; or ② metformin combined with another OAD for stable treatment for ≥ 3 months; 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. Received insulin therapy within 1 year prior to screening (excluding short-term therapy [continuous treatment ≤14 days] or insulin therapy for gestational diabetes);

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

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HR17031-301

Identifier Type: -

Identifier Source: org_study_id