Type 2 Diabetes Mellitus
Conditions
Interventions
Test group:Hui Sheng degludec insulin injection, treatment for 18 weeks
Control group:Originator insulin degludec injection (Tresiba), treatment for 18 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 (both inclusive); 3. Diagnosed type 2 diabetes at least 6 months according to the criteria of WHO (1999); 4. On stable doses of metformin monotherapy or in combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-4) inhibitor, or a-glucosidase-inhibitor for at least 3 months before randomization; 5. HbA1c >7.5% and =11% during the screening; 6. BMI >18 kg/m2 and =35 kg/m2; 7. Subjects who are wlling and able to receive treatment and follow-up according to protocol requirements, and able to use a glucose meter for self-monitoring of blood glucose.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for this study: 1. Type 1 diabetes mellitus or specific types of diabetes; 2. Subjects with severe hypoglycemia within 3 months before screening; 3. Subjects with ketoacidosis or hyperosmolar hyperglycemic state within 1 month before screening; 4. Subjects with severe complications (proliferative retinopathy, history of kidney transplantation, or active peripheral vascular disease); 5. Subjects with uncontrolled hypertension after treatment (defined as SBP =160mmHg or DBP =100mmHg); 6. Subjects with cardiovascular disease within 6 months before screening, including acute myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmia, or severe heart failure (NYHA functional classification = III); 7. Subjects with new cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months before screening; 8. Subjects with severe infection or severe trauma within 1 month before screening, and are not suitable for this clinical trial assessed by the investigator; 9. Any concomitant disease or functional disorder that may interfere with the trial results judged by the investigator, including 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 or malignant tumor; 10. Subjects with impaired liver function: ALT or AST greater than 3 times of upper limit of normal (if the review is required, it is allowed to review once within one week after screening visit, and the last review results shall prevail); 11. Subjects with impaired renal function: : eGFR (CKD-EPI formula) < 45 ml/min/1.73 m2 (if the review is required, it is allowed to review once within one week after screening visit, and the last review results shall prevail); 12. Subjects with 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; 13. Subjects have been treated with insulin for more than 14 days (including 14 days) within 6 months before screening; 14. Subjects who have used TZD or GLP-1 receptor agonists within 3 months before screening; 15. Use of non-diabetic drugs that may significantly affect glucose metabolism for 1 week or more within 3 months before screening, such as glucocorticoids (except inhalation and local external use), sympathetic stimulants, growth hormone, high-dose salicylates (300mg/ day and above), danazol, octreotide, and anabolic male steroids; 16. Subjects who was accompanied by a history of thyroid disease that failed to be controlled with a stable drug dose, and clinically significant abnormalities were showed in thyroid function test results during screening; 17. Known to be allergic to insulin, insulin analogues or ingredients in the preparations; 18. Subjects who have donated blood or received blood transfusion treatment within 3 months before screening, or who planned to donate blood during the trial; 19. Subjects who have been enrolled in clinical studies of other drugs or devices within 3 months before participating in this trial; 20. Subjects with a history of drug or alcohol abuse within 6 months before screening; 21. Known to be pregnant (determined by pregnant test at screening), females preparing for pregnancy or lactation during the trial,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c ;The proportion of patients achieving HbA1c =6.5%;The proportion of patients achieving HbA1c <7.0%;The change from baseline in FPG ;The change from baseline in FPG ;The change from baseline in standard deviation of blood glucose (SDBG);Adverse events reported throughout the trial;Hypoglycemia reported throughout the trial;Vital signs;Physical examination;Laboratory test (routine blood parameters, urine routines, and blood biochemical parameters);12-lead electrocardiogram test; | — |
Countries
China
Contacts
Public ContactJi Linong
Peking University People's Hospital
Outcome results
None listed