Phase 3 Study of Insulin Degludec for Type 2 Diabetes
Novo Nordisk announced results from a Phase 3 study of its investigational ultra-long-acting insulin degludec. The insulin significantly reduced the rate of hypoglycemia at night in adults with type 2 diabetes while obtaining equivalent improvement in glucose control compared with insulin glargine (Lantus; Sanofi Aventis) over a 52-week period. The study also found that insulin degludec had significantly lower rates of severe hypoglycemia compared to insulin glargine.
This randomized, open-label, non-inferiority, treat-to-target trial compared efficacy and safety of insulin degludec to insulin glargine. Both insulins were given once-daily in 1,030 insulin-naïve type 2 diabetes adults inadequately controlled with oral anti-diabetic medications. Findings of the study include:
-Nocturnal hypoglycemic rates were significantly lower by 36% with insulin degludec than with insulin glargine (0.25 vs. 0.39 episodes per patient per year; P=0.04).
-Overall confirmed hypoglycemic rates were 1.52 vs. 1.85 episodes per patient per year for insulin degludec and insulin glargine respectively (P=0.11).
-At one year, this trial demonstrated comparable HbA1c reductions with insulin degludec versus insulin glargine (-1.06% vs. -1.19%).
-Fasting plasma glucose (FPG) reductions were significantly greater with insulin degludec than with insulin glargine (-67.7mg/dL vs. -59.5mg/dL, estimated treatment difference (EDT) -7.7mg/dL, P=0.005).
Long acting insulin formulations work by mimicking the body's basal insulin secretion for extended control of blood glucose levels.
For more information call (800) 727-6500 or visit www.novonordisk-us.com.