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. 

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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.

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