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

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

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called HR17031 to see how well it works compared to a standard treatment, insulin glargine, for adults with type 2 diabetes. The researchers want to find out which treatment is more effective in lowering blood sugar levels, as measured by a test called HbA1c, and how safe each treatment is by tracking any side effects or low blood sugar events. The trial is currently active but not recruiting new participants.

To be eligible for this trial, participants must be between the ages of 18 and 75 and have been diagnosed with type 2 diabetes for at least 90 days. They should also have a stable daily insulin dose and have been on a medication called metformin for at least 60 days. Participants will need to monitor their blood sugar levels and keep a diary of their health. It’s important to note that certain health conditions or recent treatments may exclude someone from participating, such as severe heart problems or certain medications. Overall, this trial aims to provide valuable information that could help improve diabetes management for many people.

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.