A Study 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 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)

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

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.