Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
Interventions
SHR-3167 injection.
DRUGSHR-3167 Injection Placebo
SHR-3167 injection placebo.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a Phase II clinical trial to evaluate the 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females, 18-65 years old at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to day of screening. 3. 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. 4. 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.
Exclusion criteria
1. Uncontrollable hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening. 2. Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes. 3. Known or suspected allergy or intolerance to the test drug or excipient. 4. There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months. 5. There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases. 6. Malignancy within 5 years prior to screening or high risk of recurrence. 7. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening. 8. Participated in clinical trials of any drug or medical device within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participants who experienced at least one hypoglycemic event. | From the baseline to 20-weeks treatment. |
Secondary
| Measure | Time frame |
|---|---|
| The event rate of hypoglycemic events. | From the baseline to 20-weeks treatment. |
| Change in glycosylated hemoglobin (HbA1c) from baseline. | From the baseline to 20-weeks treatment. |
| Change in fasting plasma glucose (FPG) from baseline. | From the baseline to 20-weeks treatment. |
| The relative change in HbA1c after 20-weeks treatment compared to the baseline level. | From the baseline to 20-weeks treatment. |
Countries
China
Outcome results
None listed