Type 2 Diabetes Mellitus
Conditions
Interventions
Test group:Hui Sheng insulin degludec/insulin aspart injection, treatment for 24 weeks
Control group:Originator insulin degludec/insulin aspart injection (Ryzodeg), treatment for 24 weeks
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Males and females aged 18 to 75 years old (both inclusive) ; 3. Diagnosed with type 2 diabetes for 6 months or more; 4. Receiving once or twice daily injections of basal or premixed insulin (including human insulin or insulin analogues) with or without oral antidiabetic drugs (OAD, including metformin and/or SGLT-2 inhibitors and/or a-glucosidase inhibitors and/or DPP-4 inhibitors and/or thiazolidinediones [TZDs]), the above treatment regimen should be at steady doses for at least 8 weeks prior to randomisation ("stable basal or premixed insulin dose" is defined as no more than a 10% change in monthly dose); 5. At screening, HbA1c (glycosylated haemoglobin) >7.5% and =11.0% measured by the study center; 6. Body mass index (BMI) > 18.5 kg/m2 and =35 kg/m2; 7. Patients who are willing and able to receive treatment and follow-up visits as required in the protocol, and able to use glucometer for self-monitoring of blood glucose.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for this study: 1. Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly irregular eating habits; 2. Use of sulfonylureas or glitinides for more than one consecutive week before screening, or use of once-daily glucagon-like peptide 1 (GLP-1) receptor agonists for more than one consecutive week, with more than one time administration per week; 3. Type 1 diabetes, specific types of diabetes (such as diabetes caused by pancreatic injury, Cushing's syndrome or acromegaly, etc.); 4. Patients with severe hypoglycemia within 3 months prior to screening; 5. Patients with diabetic ketoacidosis or hyperglycemic hyperosmolar status within 1 month before screening; 6. Serious complications of diabetes: such as proliferative diabetic retinopathy, history of renal transplantation, severe peripheral vascular disease (such as amputation, chronic foot ulcer, intermittent claudication) at screening; 7. Inadequately controlled hypertension after treatment (defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg); 8. Patients with cardiac diseases, such as acute myocardial infarction within 6 months before screening, or unstable angina pectoris, arrhythmia requiring treatment, severe heart failure (NYHA functional classification = III), and not suitable for participating in this clinical trial as assessed by the investigator; 9. New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months prior to screening, and not suitable for participating in this clinical trial as assessed by the investigator; 10. Patients with severe infection or severe trauma within 1 month before screening, and are not suitable for participating in this clinical trial as assessed by the investigator; 11. Any concomitant disease or functional disorder that may interfere with the trial results as judged by the investigator, such as cardiovascular, respiratory system, gastrointestinal, pancreatic, liver, kidney, nervous system, mental, hematological system (e.g., hematologic tumor, hemolytic anemia, sickle cell disease, etc.), immune system disease; 12.History of malignancy within the past 5 years (regardless of organ system, whether treated or not, and regardless of evidence of recurrence or metastasis), except for cervical carcinoma in situ and cutaneous basal cell carcinoma that were clinically cured within 5 years of diagnosis; 13. Impaired liver function: ALT or AST greater than 3 times of upper limit of normal (if the investigator judges that reexamination is required, reexamination is allowed only once within one week after screening visit, and the result of reexamination should prevail. The reexamination report should be completed before randomization); 14. Impaired renal function: eGFR (CKD-EPI formula) < 30ml/min/1.73 m2 (if the investigator judges that reexamination is required, reexamination is allowed only once within one week after screening visit, and the result of reexamination should prevail. The reexamination report should be completed before randomization); 15. Hemoglobin = 100 g/L, or currently suffering from any disease that may cause hemolysis or red blood cells instability to affect HbA1c detection, such as hemolytic anemia; 16. Use of non-diabetic therapeutic agents that
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c at week 24;12-lead electrocardiogram test; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c at week 12;The proportion of patients achieving HbA1c <7.0% at week 24;The proportion of patients achieving HbA1c =6.5% at week 24;The change from baseline in FPG at week 12;The change from baseline in FPG at week 24;Changes from baseline in largest amplitude of glycemic excursion (LAGE), post-prandial glucose excursion (PPGE) and standard deviation of blood glucose (SDBG) at week 12;Changes from baseline in LAGE, PPGE and SDBG at week 24;Adverse events reported throughout the trial;Hypoglycemia reported throughout the trial;Immunogenicity;Vital signs;physical examination;laboratory test (routine blood parameters, urine routines, and blood biochemical parameters); | — |
Countries
China
Contacts
Public ContactLinong Ji
Peking University People's Hospital
Outcome results
None listed