Merck’s MK-1293 insulin glargine meets primary endpoint in two phase 3 trials

In both studies, MK-1293 demonstrated non-inferiority in change from baseline A1C (a measure of average blood glucose) and similar safety to Lantus (insulin glargine) after 24 weeks.

The trials met the secondary endpoint of statistical A1C equivalence between MK-1293 and Lantus which demonstrated that the investigational treatment was similar, within a certain range, to the reference therapy.

Merck vice president of late stage development, diabetes and endocrinology Peter Stein said: "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.

"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."

MK-1293 has the similar amino acid sequence as Lantus, the originator insulin glargine.

The development of MK-1293 builds on the February 2013 agreement between Merck and Samsung Bioepis.

Merck is responsible for the clinical development, manufacturing and, if approved, commercialization of MK-1293. Samsung Bioepis is partially funding its development.