Adult Patients With Type 2 Diabetes
Conditions
Brief 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.
Interventions
HR17031 injection
DRUGinsulin glargine
insulin glargine
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c from baseline to week 26 | from baseline to week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to week 26 | from baseline to week 26 |
| Proportion of subjects achieved HbA1c<7.0% and no weight gain at week 26 | at week 26 |
| Daily Insulin dose at week 26 | at week 26 |
| Proportion of subjects achieved HbA1c<7.0% at week 26 | at week 26 |
| Changes in FPG from baseline to week 26 | from baseline to week 26 |
| Hypoglycemic event from screening to week 27 | from screening to week 27 |
| Adverse events from screening to week 27 | from screening to week 27 |
| The proportion of subjects achieved HbA1c≤6.5% at week 26 | at week 26 |
Countries
China
Outcome results
None listed