Lilly Announces Phase III Clinical Trial of Basaglar® in Chinese Adults with Type 1 Diabetes Met Primary Endpoint

On May 29, Eli Lilly and Company announced a study in Chinese adult patients with type 1 diabetes comparing the long-acting basal insulin analog Basaglar® (insulin glargine) with Lantus^®The 24-week Phase III clinical study (14L-GH-ABES) on the efficacy and safety of (insulin glargine) met its primary endpoint.

The ABES study is a comparison of the long-acting basal insulin analog Basaglar^®A Prospective, Randomized, Open-Label, Multicenter, Phase III Controlled Clinical Study Evaluating the Efficacy and Safety of Basaglar® Versus Lantus® in Combination with Mealtime Insulin for the Treatment of Chinese Adult Patients with Type 1 Diabetes Mellitus (T1DM) (ClinicalTrials.gov, NCT03338023). The primary endpoint was the efficacy of Basaglar® in combination with three-times-daily (TID) preprandial insulin lispro in Chinese adult patients with T1DM.^®Once-daily dosing (QD) is non-inferior to Lantus^®QD。

This study enrolled a total of 272 patients with type 1 diabetes mellitus (T1DM) and was conducted across 20 research centers in China. The study confirmed that Basaglar was non-inferior to Lantus within a non-inferiority margin of 0.4%.^®, Lantus^®nor inferior to Basaglar^®(LS Mean Difference [Basaglar^®- Lantus^®] = -0.12%, 95% CI: -0.32% to 0.08%), meeting Basaglar^®and Lantus^®Equivalent endpoints. There were no statistically significant differences in the overall incidence and total rates of overall hypoglycemia, nocturnal hypoglycemia, and severe hypoglycemia between the two treatment groups. The incidence of adverse events and injection site reactions during treatment was similar in both groups. The study confirmed Basaglar^®It can provide a once-daily (QD), well-tolerated, and effective basal insulin option for patients with type 1 diabetes mellitus (T1DM) in China, with efficacy and safety profiles comparable to those of Lantus.^®(similar to insulin glargine).

Basaglar^®It is Lantus, under Sanofi-Aventis.^®biosimilar of (insulin glargine [rDNA origin] injection), both of which are long-acting human insulin analogs indicated for the treatment of diabetes. Basaglar^®primary amino acid sequence with Lantus^®have the same active ingredient as Lantus^®It has the same dosage form. Its differences from human insulin lie in the substitution of one amino acid at position A21 (asparagine replaced by glycine) on the A chain and the addition of two arginine residues at the C-terminus of the B chain. Compared with conventional insulin, long-acting insulin analogs (insulin glargine) provide more benefits than previous treatments such as intermediate-acting insulin (NPH), including a reduced incidence of nocturnal hypoglycemia, better fasting blood glucose control, and improved quality of life.

Basaglar^®(Glargine insulin) 100 units/mL was first granted marketing authorization by the European Medicines Agency on September 9, 2014. It has currently received marketing authorization in 87 countries, including the European Union (including the European Economic Area), the United States, Canada, Australia, Japan, and Switzerland.

Note: The drug Basaglar mentioned in the text^®Not yet marketed in China.