MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) demonstrated similar efficacy and safety in patients with type 2 diabetes (T2D), according to new findings published in Diabetes, Obesity and Metabolism.
In the current phase 3 trial, the efficacy and safety of both drugs were compared in participants with T2D. The cohort included 531 participants with T2D (HbA1c ≤11.0%) who were eligible for or currently taking basal insulin (≥10 U/day) and were randomly assigned to either once-daily Mk-Gla (n=263) or Sa-Gla (n=263).
The objective was to compare the clinical efficacy and safety of Mk-Gla with the approved reference insulin glargine (Sa-Gla) and to demonstrate noninferiority and equivalence between the 2 agents with regard to HbA1c change from baseline after 24 weeks of treatment.
Of the 531 participants who were randomly assigned to either Mk-Gla or Sa-Gla, 484 participants completed the 24-week study.
Both treatment groups achieved clinically meaningful reduction in HbA1c from ~8.3% (67 mmol/mol) at baseline to ~7.2% (55 mmol/mol) at week 24, and the proportions of patients who met the target HbA1c values of <7.0% (53 mmol/mol) and <6.5% (48 mmol/mol) were similar for both groups. Both groups also had similar reductions in fasting plasma glucose, and serious adverse events were also similar between the 2 groups.
“Mk-Gla is a follow-on/biosimilar insulin glargine with clinical properties that are highly similar to those of Sa-Gla,” the authors write. “Therefore, Mk-Gla is expected to be a safe and effective treatment option for people with [T2D] for whom basal insulin therapy is indicated.”
Hollander PA, Carofano WL, Lam RLH, et al. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: a randomized, open-label clinical trial [published online May 14, 2018]. Diabetes Obes Met. doi: 10.1111/dom.13363