Lilly's Tirzepatide Injection Gains New Indication in China for Use with Insulin Therapy in Type 2 Diabetes

Jul 29, 2025 09:13 CST Updated 09:13

Eli Lilly

Global Pharmaceutical R&D and Production Company

｜Edited by the Content Team of Zhong Peptide Biochemical

2025Year July28Day，Eli Lilly Announces Mufengda^®(Tirzepatide Injection) has been approved by the National Medical Products Administration (NMPA) of China for a new indication: to be used in combination with insulin (with or without oral hypoglycemic agents) on the basis of diet control and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM).

This new addition of indications is mainly based onNorthProfessor Guo Lixin, Director of the Endocrinology Department at Beijing Hospital · National Center for GeriatricsThe SURPASS-CN-INS study, as the principal investigator.

Professor Guo stated: "In the study, tirzepatide demonstrated clinically significant improvements in blood sugar control and weight reduction compared to placebo in Chinese patients with T2DM who had previously been treated with insulin, without increasing the risk of hypoglycemia. This result provides strong evidence for the combination therapy of tirzepatide and insulin."

The 40-week study enrolled 257 Chinese participants with T2DM (baseline mean age 56.7 years; diabetes duration 12.1 years; HbA1c 8.71%; BMI 27.1 kg/m²).²), aimed at evaluating patients receiving basal insulin monotherapyIn Chinese T2DM participants treated with or without metformin combined with or without SGLT-2i, the efficacy and safety of tirzepatide 5mg, 10mg, or 15mg were compared with those of placebo. The study achieved its primary endpoint and all key secondary endpoints: the three tirzepatide dose groups showed H at week 40.bA1c, weight, and fasting blood glucose changes from baseline were significantly better in the treatment group compared to the placebo group; additionally, the proportion of participants achieving HbA1c targets was also significantly higher in the tirzepatide 10mg and 15mg groups compared to the placebo group.

Note: The efficacy estimation objective was used. The study did not predefine the comparison of the tirzepatide 5mg group with the placebo group in terms of the HbA1c <5.7% achievement rate at Week 40 as a primary or key secondary endpoint.

***Compared with placebo, p value < 0.001.*Compared with placebo, p-value < 0.05.

The safety profile of tirzepatide was consistent with previous SURPASS series studies, with the most common adverse events being gastrointestinal adverse events, mostly mild to moderate in severity. The incidence of hypoglycemia in the tirzepatide group was similar to that in the placebo group, and no severe hypoglycemic events were reported in the study.

AboutTirzepatide

Tirzepatide is a dual receptor agonist drug for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). Tirzepatide acts on the root causes of obesity, reducing appetite and food intake.Previously, tirzepatide has been approved by the NMPA for use in: adult patients with type 2 diabetes whose blood glucose is inadequately controlled on metformin and/or sulfonylurea therapy in addition to diet and exercise; and for long-term weight management in adults with an initial body mass index (BMI) meeting the following criteria in conjunction with diet control and increased physical activity: ≥28 kg/m² (obesity), or ≥24 kg/m².㎡(Overweight) accompanied by at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.).

About Eli Lilly and Company

Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, manufacturing, and marketing of medicines, dedicated to improving human health through innovation. Eli Lilly and Company was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876. The company's founder was committed to producing high-quality medicines to meet genuine medical needs.

Source:

1.Eli Lilly