Follow-on biologic drug MK-1293 deemed non-inferior to insulin glargine (Lantus).
Merck recently announced positive results from a pair of phase 3 studies involving the drug MK-1293, which is a follow-on biologic insulin glargine (Lantus) for the treatment of patients with diabetes.
MK-1293 has the same amino acid sequence as Lantus, but cannot be considered a biosimilar because it is not identical.
In both studies, the drug reached its primary endpoint, showing non-inferiority and similar safety to insulin glargine (Lantus), according to a press release from Merck.
Included in 1 of the studies were 263 patients with type 1 diabetes. Researchers analyzed the efficacy and safety of MK-1293 compared with Lantus.
The primary endpoint of this study was to demonstrate non-inferiority of change from baseline A1C at 24 weeks. This endpoint was met, showing non-inferiority with a least-squares mean difference in A1C of 0.04% (MK-1293 minus Lantus).
The primary safety endpoint of this drug was measured by anti-insulin antibody development. Researchers found that 74% of patients taking Lantus and 70% of patients taking MK-1293 had an AIA positive result during the study.
Researchers found no difference in safety endpoints regarding adverse effects. In the second study, researchers included 266 patients with type 2 diabetes whose condition could not be controlled with diet and exercise.
The primary efficacy endpoint for this study was non-inferiority of change from baseline A1C at week 24, which MK-1293 met with a least-squares mean difference in A1C of 0.03% (MK-1293 minus Lantus), according to the study.
The primary safety objective was anti-insulin antibody development. Researchers found that 29% of patients taking Lantus and 34.7% of patients taking MK-1293 had positive AIA status.
Researchers also did not find any clinically meaningful difference between groups regarding safety endpoints, according to Merck.
“The investigational agent MK-1293 represents Merck’s entry into insulin therapeutics and into treatments that may be useful for patients with type 1 diabetes, and we are pleased with these Phase 3 results,” concluded Peter Stein, MD, vice president of late stage development, diabetes and endocrinology at Merck. “As a follow-on biologic, MK-1293 has the potential to offer a treatment option for pediatric and adult patients with type 1 diabetes and for adults with type 2 diabetes who use basal insulin to help control their glucose levels.”