A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin

Korábbi kezelés

• Have a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
• Have hyperthyroidism (including clinical hyperthyroidism and subclinical hyperthyroidism), regardless of whether it is in the treatment stage; or hypothyroidism that requires treatment (those who have received a stable dose of thyroid hormone replacement therapy for ≥ 90 days and are willing to continue the stable treatment during the trial are excluded).
• Malignancy within 5 years prior to screening or high risk of recurrence.
• Have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.

Más betegség

• Uncontrolled 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.
• Have acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.

• Males and females, Age≥18 years old at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days prior to day of screening.
• Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to day of screening.
• 7.0% ≤ HbA1c ≤ 10.0% at screening.