Phase 3a Trial Update of Insulin Degludec for Diabetes

Novo Nordisk announced new Phase 3a trial data of insulin degludec in the management of diabetes.

A randomized, open-label, treat-to-target, 2-year (1 year initial and 1 year extension) phase 3a study included 1,030 patients with type 2 diabetes not previously treated with insulin, of which 659 completed 2 years of treatment. The trial compared the efficacy and safety of once-daily insulin degludec vs. once-daily insulin glargine (Lantus; Sanofi Aventis), both in combination with oral antidiabetic drugs. The rates of overall hypoglycemia were similar between the two groups (1.72 [insulin degludec] vs. 2.05 [insulin glargine] episodes per patient per year, P=NS). While the rates of severe hypoglycemia were infrequent, they were significantly lower with insulin degludec compared with insulin glargine (0.01 [insulin degludec] vs. 0.02 [insulin glargine] episodes per patient per year, P=0.02). Patients had a 43% lower rate of night-time hypoglycemia when using insulin degludec compared with those using insulin glargine (0.27 [insulin degludec] vs. 0.46 [insulin glargine] episodes per patient per year, P<0.001) with equivalent improvements in glucose control.

In a separate, prospectively planned meta-analysis also announced, patient level data from 4,330 patients in seven randomized, open-label, treat-to-target Phase 3a trials of 26 or 52 weeks showed that insulin degludec significantly reduced the rate of night-time hypoglycemia in adults with type 1 and type 2 diabetes, while obtaining equivalent improvements in glucose control, when compared with insulin glargine.

Patients with type 2 diabetes who had not previously been treated with insulin showed the greatest reductions in night-time hypoglycemia when using insulin degludec compared with insulin glargine:

  • 36% (P<0.05) reduction in night-time hypoglycemia with insulin degludec compared with insulin glargine (0.3, 0.2 and 0.8 episodes per patient per year with insulin degludec vs. 0.4, 0.3 and 1.2 episodes per patient per year with insulin glargine for the trials 3579, 3672 and 3586 respectively) .
  • 17% (P<0.05) reduction in overall hypoglycemia with insulin degludec compared with insulin glargine (1.5, 1.2 and 3 episodes per patient per year with insulin degludec vs. 1.8, 1.4 and 3.7 episodes per patient per year with insulin glargine for the trials 3579, 3672 and 3586 respectively).
  • 86% (P<0.05) reduction in the rates of severe hypoglycemia with insulin degludec compared with insulin glargine (0.003, 0 and 0 episodes per patient per year with insulin degludec vs. 0.02, 0 and 0.01 episodes per patient per year with insulin glargine for the trials 3579, 3672 and 3586 respectively).

Insulin degludec is a basal insulin analogue with an ultra-long duration of action that extends beyond 42 hours with a flat and stable profile.

For more information call (800) 727-6500 or visit www.novonordisk-us.com.