US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced that the National Medical Products Administration (NMPA) in China has approved Mounjaro (tirzepatide) for use in combination with insulin (with or without oral antidiabetic agents). This approval is for improving glycemic control in adult patients with type 2 diabetes mellitus (T2DM), based on diet control and exercise.
Clinical Trial Support
The approval is supported by the SURPASS-CN-INS study conducted in China. This 40-week trial enrolled 257 Chinese participants with T2DM. The study evaluated the efficacy and safety of tirzepatide versus placebo when added to basal insulin monotherapy or basal insulin combined with metformin, with or without an SGLT-2 inhibitor. The primary endpoints were successfully met, with all three tirzepatide dosage groups (5 mg, 10 mg, and 15 mg) showing significantly greater reductions in HbA1c, body weight, and fasting blood glucose from baseline at Week 40 compared to the placebo group. Additionally, the 10 mg and 15 mg groups demonstrated superior performance in achieving HbA1c targets compared to the placebo. The safety profile of tirzepatide was consistent with previous studies.-Fineline Info & Tech
