Type 2 diabetes drug receives label update for moderate renal impairment

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of liraglutide (Victoza®) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe liraglutide, the once-daily human glucagon-like peptide-1 (GLP-1) analogue, to adults with type 2 diabetes and moderate renal impairment without dose adjustments.

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.

“Renal impairment is very common in patients with type 2 diabetes, and the choice of glucose-lowering therapies available to people with both conditions is limited”, said Melanie Davies, professor of Diabetes Medicine and honorary consultant, Diabetes Research Centre, University of Leicester, UK and clinical trial investigator. “This label update gives physicians an additional treatment option to help their patients with type 2 diabetes and moderate renal impairment achieve glycaemic control.”

The CHMP recommendation for liraglutide was based on efficacy and safety data from the LIRA-RENAL phase 3b clinical trial. This was a 26-week, double-blind, randomised, controlled study investigated the efficacy and safety of liraglutide compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination thereof in adults with type 2 diabetes and moderate renal impairment.

Study results include: 

• The addition of once-daily liraglutide versus placebo in adults with type 2 diabetes and moderate renal impairment showed statistically significantly greater reduction in mean HbA1c (-1.05% vs. -0.38%) and body weight (-2.41 kg vs -1.09 kg) 
• Adults treated with liraglutide experienced no change in renal function (estimated glomerular filtration rate [eGFR] (Modification of Diet in Renal Disease [MDRD]) change from baseline: liraglutide -1%; placebo +1%) 
• There was a comparable risk of hypoglycaemic episodes between the two treatment groups. The safety profile of liraglutide was generally similar to that observed in other studies of the treatment

Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, liraglutide works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, liraglutide  is associated with a low rate of hypoglycaemia. In addition, liraglutide reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered food intake. Liraglutide is not approved for weight management or for use in people who do not have type 2 diabetes.