A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study to Compare the Efficacy and Safety of Insulin Degludec Injection Versus Tresiba® in Subjects With Type 2 Diabetes

This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Inclusion Criteria:

1. Type 2 diabetes (diagnosed clinically) for at least 6 months.
2. Aged ≥18 and ≤70 years old, male or female.
3. Subjects who were treated with a stable dose of oral hypoglycemic agents for more than 3 months before the random visit.
4. HbA1c is in the range of 7.5% -11.0 % by local laboratory analysis.
5. Body mass index (BMI) ≥18 kg/m2 and ≤40kg/m2.
6. Patients must give informed consent to this study before the trial, and voluntarily sign an informed consent form.
7. Patients who can communicate well with the investigator and can complete the study in accordance with the research regulations.

Exclusion Criteria:

1. Diagnosed as type 1 diabetes or other types of diabetes.
2. Patients who have received insulin therapy for more than 7 days within 3 months before screening .
3. Patients who have received a thiazolidinedione (TZD) or GLP-1 receptor agonist within 3 months before screening.
4. Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
5. Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
6. Patients with hypoglycemia who have recurring severe events with conscious and/or physical changes within 3 months before screening and need help from others.
7. Those who have experienced acute metabolic complications (ketoacidosis, lactic acidosis, or hyperosmolar coma, etc.) within 3 months before screening.
8. Patients with obvious liver and kidney dysfunction.
9. Hemoglobin <100g/L.
10. When the virological test during the screening period shows that any of the following is met:

(1) HCV（hepatitis C virus） antibody is positive, and the HCV virus titer test value exceeds the upper limit of normal value; (2) HBsAg（Hepatitis B surface antigen） is positive and the HBV（hepatitis B virus） DNA test value exceeds the upper limit of normal; (3) HIV（human immunodeficiency virus） positive; (4) Active syphilis;

11. At the time of screening, there are thyroid diseases that have not been controlled with stable doses of drugs within 6 months, and the results of thyroid function tests during the screening period are abnormal and have clinical significance.

12. Uncontrolled or poorly treated high blood pressure.

13. Those with decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or blood vessel reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) occurred within 6 months before screening.

14. Those with proliferative retinopathy or macular degeneration (macular edema) that requires urgent treatment during screening.

15. Once diagnosed as malignant tumor (except for basal cell carcinoma or squamous cell skin cancer).

16. Patients with severe chronic gastrointestinal diseases (such as active peptic ulcer) and severe infections.

17. Those who are allergic to any ingredient in insulin deglu injection and Novota®.

18.Those who participated in any other clinical trials within 3 months before screening (excluding those who failed the screening or did not use study drugs for other reasons).

19. Pregnant women, lactating women, women of childbearing age who do not take appropriate contraceptive measures during the trial period (sterilization, intrauterine device, oral contraceptives or barrier contraception).

20. Those who are judged by the investigator to be unsuitable to participate in the trial.