The Committee for Medicinal Products for Human Use (CHMP) reviewed data from a LIRA-RENAL phase 3b clinical trial and approved Victoza (liraglutide) for adults with type 2 diabetes and moderate renal impairment. The announcement will provide type 2 diabetics with renal issues with a viable, approved therapy for controlling the condition.
Type 2 diabetes is associated with long-term complications, including heart disease, strokes, diabetic retinopathy and kidney failure (also known as renal impairment or insufficiency), where kidneys fail to filter properly waste products from the blood. The results retrieved from the LIRA-RENAL phase 3b clinical trial for Victoza (liraglutide) efficacy and safety led to the approval of this therapeutic to treat renal impairment in these patients.
As Melanie Davies, professor of Diabetes Medicine and honorary consultant, Diabetes Research Centre, University of Leicester, UK and clinical trial investigator noted, “Renal impairment is very common in patients with type 2 diabetes, and the choice of glucose-lowering therapies available to people with both conditions are limited. This label updates gives physicians an additional treatment option to help their patients with type 2 diabetes and moderate renal impairment achieve glycemic control.”
The LIRA-RENAL phase 3b trial investigated the efficacy and safety of a single daily dose of Victoza (liraglutide) when administered in combination with oral antidiabetic treatment in adults with type 2 diabetes and moderate renal impairment. The 26-week trial resulted in a significant reduction in plasma glucose levels (translated from measuring the levels of hemoglobin A1c, HbA1c) and body weight, when compared to placebo controls. Additionally, no alterations in renal function were observed during the treatment. Adverse effects include a risk of hypoglycemic episodes, but the risk was the same between Victoza (liraglutide) and placebo-treated groups.
Victoza (liraglutide) is a human analog for the human glucagon-like peptide-1 (GLP-1), with a 97 percent similarity in amino acid sequence. Thus, Victoza (liraglutide) induces the release of insulin from beta cells while reducing the levels of secretion of glucagon, upon high levels of glucose in the blood. Victoza (liraglutide) reduces both body weight and body-fat mass. In the US, Victoza (liraglutide) was approved in 2010 as supplement therapeutics to improve blood hyperglycemia in adult patients with type 2 diabetes.