New Data on Liraglutide (Victoza) in Adults With Type-2 Diabetes
Phase III study shows increased glycemic control versus placebo
Data from a new phase III study has demonstrated that once-daily liraglutide (rDNA origin) injection (Victoza, Novo Nordisk) provided greater glycemic control compared with placebo with no worsening of renal function in adults with type-2 diabetes and moderate renal impairment.
The data were presented June 14 at the 74th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California.
The 26-week, double-blind, randomized study investigated the efficacy and safety of liraglutide compared with that of placebo when added to pre-existing oral antidiabetic treatment, insulin, or a combination of both.
The study showed that adults with type-2 diabetes and moderate renal impairment (i.e., those with stage-3 chronic kidney disease) treated with liraglutide experienced significantly greater improvements in mean hemoglobin A1c (HbA1c) (–1.05% vs. –0.38%, respectively; P < 0.0001); were more likely to achieve a target HbA1c of less than 7% (52.8% vs. 19.5%; P < 0.0001); and experienced significantly greater weight loss from baseline (–5.31 lbs vs. –2.40 lbs; P = 0.0052) compared with placebo. The investigators observed no worsening of renal function and a lower incidence of hypoglycemia during treatment with liraglutide compared with placebo.
Overall, there is limited experience with liraglutide in patients with mild, moderate, or severe renal impairment, including end-stage renal disease. Liraglutide should be used with caution in these patients.
The most common adverse events (AEs) were gastrointestinal in nature. These included nausea (21.4% liraglutide vs. 4.4% placebo), vomiting (12.1% vs. 2.2%), diarrhea (7.1% vs. 2.9%), and constipation (5.7% vs. 1.5%). Additional frequent AEs included renal impairment (5.0% vs. 5.8%), nasopharyngitis (5.0% vs. 11.7%), headache (5.0% vs. 2.9%), increased lipase (15.0% vs. 8.8%), and decreased glomerular filtration rate (6.4% vs. 5.1%).
The study involved 277 adults with type-2 diabetes and moderate renal impairment. The subjects were randomly assigned to receive either liraglutide injection 1.8 mg (the highest dose available) or placebo as add-on to existing oral antidiabetic treatments and/or insulin therapy. The mean ages of the subjects in the liraglutide and placebo groups were 68.0 years and 66.3 years, respectively. Renal function was measured by the change in the estimated glomerular filtration rate from baseline.
Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog. It was approved by the FDA in January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type-2 diabetes.
Source: Novo Nordisk; June 14, 2014.