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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

Conditions: Adult Patients With Type 2 Diabetes

Treatments: Drug: HR17031 injection; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06871761

HR17031-302

Details and patient eligibility

About

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.

Enrollment: 393 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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393 participants in 2 patient groups

Treatment group A: HR17031 injection

Experimental group

Treatment:

Drug: HR17031 injection

Treatment group B: insulin glargine

Active Comparator group

Treatment:

Drug: insulin glargine