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

Korábbi kezelés

• Known or suspected allergy to the investigational drug product or its components or excipients;
• Systemic glucocorticoid use within 3 months prior to screening;
• Use of weight loss drugs within 3 months prior to screening;
• Received insulin therapy within 1 year prior to screening (excluding short-term therapy [continuous treatment ≤14 days] or insulin therapy for gestational diabetes);
• 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;
• Previous history of pancreatitis (acute or chronic);
• 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;

Más betegség

• (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
• Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
• Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.

Egyéb

• Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
• Known or suspected abuse of alcohol or narcotics;

• Male or female, aged 18-75 years at the time of signing the informed consent (both ends included);
• Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included);
• Diagnosed with type 2 diabetes for at least 90 days prior to screening;
• Tested by local laboratory, HbA1c is 7.5%-11% (including both ends);
• Before screening, the daily basal insulin dose had been stabilized at 20-40 U/day (including both ends) for at least 60 days;
• 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.
• Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.