Sanofi Announces Positive Top-Line Results from Phase III LixiLan-L China Trial of iGlarLixi in Type 2 Diabetes Patients

SHANGHAI, Oct. 11, 2021 /PRNewswire/ -- Sanofi China announced at the 57th Annual Meeting of the European Association for the Study of Diabetes (EASD) that SOLIQUA, a fixed-ratio combination of basal insulin and a GLP-1 receptor agonist (GLP-1RA) developed by the company in China^® The Phase III clinical trial of (iGlarLixi)*, the LixiLan-L China study, met its primary efficacy endpoint and secondary endpoints.

The LixiLan-L China study is a randomized, open-label, active-controlled, parallel-group clinical trial with a 30-week treatment duration, designed to evaluate the efficacy and safety of iGlarLixi. A total of 426 Chinese adult subjects were enrolled in the trial, all of whom had been diagnosed with type 2 diabetes for more than one year and had inadequate glycemic control despite treatment with basal insulin (with or without oral antidiabetic drugs).

The results of the LixiLan-L China study demonstrated that, compared with the basal insulin therapy group, patients treated with iGlarLixi met the prespecified primary efficacy endpoint for glycated hemoglobin (HbA1c) reduction. At week 30 of treatment, the mean HbA1c was 6.7% in the iGlarLixi group versus 7.4% in the basal insulin group. The proportion of patients achieving the HbA1c target (HbA1c <7%) was 63% in the iGlarLixi group compared with 30% in the basal insulin group. Furthermore, the trial also met its prespecified secondary endpoints, with the iGlarLixi group demonstrating superiority over the basal insulin group in postprandial glucose control, weight control, and hypoglycemia incidence.

LixiLan-L Prof. Guo Xiaohui, Principal Investigator of the China study at the Department of Endocrinology, Peking University First Hospital, stated：“The results of this clinical trial confirm the efficacy and safety of iGlarLixi compared with basal insulin in patients with inadequate glycemic control despite treatment with basal insulin with or without up to two oral antidiabetic drugs. We look forward to iGlarLixi providing a novel glucose-lowering treatment option for a broad population of Chinese patients with diabetes in the future.”

Dr. Chengming Gu, Head of Medical Department, General Medicines, Sanofi Greater ChinaIndicates:“We are highly pleased with the results of this clinical trial, which clearly demonstrate the excellent glucose-lowering efficacy and safety of iGlarLixi in adult patients with type 2 diabetes in China. We hope that treatment with iGlarLixi will help a broader population of Chinese patients with diabetes achieve improved glycemic management goals, further facilitating optimal glycemic target attainment.”

^*SOLIQUA^®(iGlarLixi) not yet approved in China