Type 2 Diabetes
Conditions
Brief summary
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
Interventions
SHR-3167 injection.
Insulin Degludec injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained before any trial-related activities. 2. Age 18\~59 years at screening (including cut-off values at both ends). 3. Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening. 4. 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.
Exclusion criteria
1. Poor blood pressure control at screening. 2. Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods. 3. Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening. 4. 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. 5. Malignancy or history of malignancy within 5 years prior to screening. 6. Participation in any clinical trial of an approved or unapproved investigational drug/medical device within 90 days prior to screening. 7. Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss). | From 0 to 168 hours after SHR-3167 administration. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed SHR-3167 concentration (Cmax, ss). | From 0 to 168 hours after SHR-3167 administration. |
| Adverse events (AEs). | 21 weeks to 43 weeks. |
| Hypoglycemic events. | 21 weeks to 43 weeks. |
Countries
China
Contacts
CONTACTHan Jianting
Outcome results
None listed