The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
Informed consent obtained before any trial-related activities.
Age 18~59 years at screening (including cut-off values at both ends).
Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening.
Female subjects of childbearing potential and their partners are male subjects of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 3 months after signing the informed consent form and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Poor blood pressure control at screening.
Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods.
Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening.
Positive test for hepatitis B surface antigen (HBsAg), HIV antibody, treponema pallidum specific antibody, or hepatitis C virus antibody; or the investigator judges that the subject is in the incubation or active phase of the above infection.
Single group
SHR-3167 Injection
DrugSHR-3167 injection.
Insulin Degludec Injection
DrugInsulin Degludec injection.
Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss).
Maximum observed SHR-3167 concentration (Cmax, ss).
Adverse events (AEs).
Hypoglycemic events.
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