1 September 2016 - Novo Nordisk has announced that the European Commission has approved the expanded use of Xultophy (insulin degludec with liraglutide), a combination of a long-acting basal insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide) in one pen, in adults with type 2 diabetes and moderate renal impairment (CrCL 30-59 mL/min).

The authorisation covers all 28 European Union member states, Norway and Iceland.

Renal impairment is a challenging and common long-term complication of type 2 diabetes that requires frequent monitoring of blood glucose levels and kidney function. Depending on age, duration of diabetes and blood glucose control, up to 40% of people with type 2 diabetes will develop some degree of renal impairment.

"The label expansion of Xultophy (insulin degludec with liraglutide) is a very important milestone as the current treatment options are very limited for people with type 2 diabetes, and especially for those living with obesity*, who also suffer from moderate renal impairment," said Andrew Boulton, Professor of Medicine at the University of Manchester and Consultant Physician at Manchester Royal Infirmary.

The approval is based on data from the LIRA-RENAL phase 3b clinical trial, which examined the efficacy and safety of liraglutide versus placebo as an add-on to existing diabetes medication in people with type 2 diabetes with moderate renal impairment.

Insulin degludec with liraglutide is approved for the treatment of adults with type 2 diabetes to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.

Read Novo Nordisk press release