Novo Nordisk says DegludecPlus provides superior glycemic control vs Lantus

Denmark-based insulin giant Novo Nordisk (NVO: N) yesterday announced positive clinical results from a 26-week Phase IIIa treat-to-target study comparing DegludecPlus, a soluble combination of ultra-long-acting insulin degludec and insulin aspart, to insulin glargine (Sanofi’s blockbuster drug Lantus) in Japanese people with type 2 diabetes inadequately controlled on oral antidiabetic drugs. This is the 18th announced Phase IIIa study in the Degludec and DegludecPlus clinical trial development program.

Novo Nordisk recently filed with the European Medicines Agency for approval of Degludec and DegludecPlus for the treatment of type 2 diabetes and then said it was expecting to file for US approval within a couple of weeks (The Pharma Letter September 28).

In this 26-week study, 296 Japanese people with type 2 diabetes were randomized 1:1 to treatment with either DegludecPlus or insulin glargine, both given once daily with or without OADs. DegludecPlus lowered the long-term glycemic control, HbA1c, by around 1.4 percentage points to 7.0%, which was statistically significantly superior to the reduction seen with insulin glargine, with an estimated treatment difference of 0.3 percentage point.