Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs
Conditions
Brief summary
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
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%-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c: Changes in HbA1c from baseline to week 26 | week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieved HbA1c<7.0% at week 26 | at week 26 |
| Change in body weight from baseline after 26 weeks of treatment | 26 weeks |
| Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26 | week 26 |
| Actual Daily Insulin dose at week 26 | week 26 |
| Proportion of subjects achieved HbA1c≤6.5% at week 26 | week 26 |
| Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment | 26 weeks |
| Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26 | week 26 |
| Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment | 12weeks |
| Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment | 12weeks |
| Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26 | at week 26 |
| Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26 | at week 26 |
| Proportion of subjects achieved HbA1c<5.7% at week 26 | at week 26 |
| Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26; | week 26; |
| Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment | 26 weeks |
| Changes in HbA1c from baseline after 52 weeks of treatment | 52 weeks |
| Changes in FBG from baseline after 52 weeks of treatment | 52 weeks |
| Changes in body weight from baseline after 52 weeks of treatment | 52 weeks |
| Proportion of subjects achieved HbA1c<7% at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c≤6.5% at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<7% without body weight gain at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52 | at week 52 |
| Proportion of subjects achieved HbA1c<5.7% at week 52 | at week 52 |
| Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52 | week 52 |
| Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment | 52 weeks |
| Actual Daily Insulin dose at week 52 | at week 52 |
| Number of Treatment-emergent Hypoglycemic event from screening to week 53 | from screening to week 53 |
| Number of Treatment-emergent Adverse Events from screening to week 53 | from screening to week 53 |
| Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27 | at week 27 |
Countries
China
Outcome results
None listed