Novo Nordisk has announced data from a new Phase 3 study on the safety and efficacy of liraglutide (Victoza) in patients with type 2 diabetes and moderate renal impairment. The results were presented at the 2014 American Diabetes Association Scientific Sessions.
The double-blind, randomized, controlled multinational Phase 3 study of 277 adults with stage 3 chronic kidney disease was conducted over 26 weeks, with patients receiving either liraglutide 1.8mg or placebo as add-on to existing oral antidiabetic treatment and/or insulin therapy. Those receiving liraglutide had significantly greater improvements in mean HbA1c vs. placebo (-1.05% vs. -0.38%; ETD -0.66% [95% CI: -0.90;-0.43]; P<0.0001), were more likely to reach target HbA1c <7% (52.8% vs. 19.5%; P<0.0001), and significantly greater weight loss from baseline (-2.41kg/5.31lbs vs. -1.09kg/2.40lbs; ETD -1.32kg/2.90lbs [95% CI: -2.24;-0.40]; P=0.0052). There was no decline in renal function and a lower incidence of hypoglycemia was observed with liraglutide vs. placebo.
Liraglutide is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes.
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