A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Prior treatment

• There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
• Malignancy within 5 years prior to screening or high risk of recurrence.
• Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
• Participated in clinical trials of any drug or medical device within 3 months prior to screening.

Other illness

• Uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
• Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
• Known or suspected allergy or intolerance to the test drug or excipient.
• There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.

Other

• There is hyperthyroidism or hypothyroidism requiring treatment.

• Males and females, 18 - 65 years old at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening.
• Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening.
• 6.5% ≤ HbA1c ≤ 10.0% at screening.