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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs

Treatments: Drug: HR17031 injection; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06881264

HR17031-301

Details and patient eligibility

About

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

Enrollment: 401 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%-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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 2 patient groups

Treatment group A: HR17031 injection

Experimental group

Treatment:

Drug: HR17031 injection

Treatment group B: insulin glargine

Experimental group

Treatment:

Drug: insulin glargine