A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Titration in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents

Korábbi kezelés

• 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.

Más betegség

• Uncontrollable hypertension: 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.

• 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 day of screening.
• During the screening process, at least one of the oral antihyperglycemic agents must be used (no more than 3 types), and the treatment must be stable for at least 2 months.
• Female participants of childbearing potential and their partners are male participants of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 4 months after signing the informed consent form and have no plans to donate eggs/sperm; Female participants of childbearing potential have a negative pregnancy test during the screening period and are not lactating.