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A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

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

A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 Injection With Insulin Glargine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin, Metformin in Combination With or Without One Other Oral Antidiabetic Drug (OAD)

NCT06871761•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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)
+2 more criteria

Locations (1)

Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 8, 2024

Primary Completion Date

May 13, 2025

Completion Date

May 13, 2025

Last Updated

January 13, 2026

Enrollment

393

ACTUAL participants

Conditions

Adult Patients With Type 2 Diabetes

Interventions

HR17031 injection

DRUG

insulin glargine

DRUG