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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Mar 6, 2025

Keywords

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Gender

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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.