Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

Inclusion criteria

• Able and willing to provide a written informed consent.
• Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
• A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
• Body mass index (BMI): 18.5~35.0 kg/m2.
• HbA1c of 7.5%~10.0% as assessed by the local laboratory.
• Insulin naïve.
• Female subjects and partners of male subjects who are of childbearing potential, have no fertility plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent form to the last dose, 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

• Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
• Poor blood pressure control at screening.
• Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
• ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
• History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
• Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease.
• Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
• Malignancy or history of malignancy within 5 years prior to screening.
• Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening.
• Participation in a clinical trial of any drug or medical device within 3 months prior to screening.
• Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.