Novo Nordisk announced that the Food and Drug Administration (FDA) has approved Xultophy 100/3.6 (insulin degludec and liraglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on <50 units of basal insulin daily or ≤1.8mg of liraglutide daily.
Xultophy is a once-daily injection that combines 100 Units of insulin degludec (Tresiba), a long-acting human insulin analog, and 3.6mg of liraglutide (Victoza), a glucagon-like peptide 1 (GLP-1) receptor agonist. Insulin degludec lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Liraglutide increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.
The FDA approval was supported by safety and efficacy data from the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL trials (n=1,393), patients with inadequate control on liraglutide or basal insulin therapy who were switched to Xultophy 100/3.6 experienced reductions in HbA1c. For patients uncontrolled on basal insulin, treatment with Xultophy 100/3.6 showed significant reductions in A1c from baseline of 1.67% and 1.94%.
Xultophy 100/3.6 will be available as 3mL prefilled pens in the first half of 2017.
For more information call (800) 727-6500 or visit Xultophy.com.