A Randomized, Open-label, Treat-to-target, Parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-3167 and Insulin Glargine in Patients With Type 2 Diabetes Mellitus With Metformin Alone or in Combination With SGLT2 Inhibitors
The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.
• 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\
• 0 kg/m2.
• HbA1c of 7.5%\
• 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.