New phase 3 study shows efficacy and safety of Victoza® for the treatment of type 2 diabetes in adults with moderate renal impairment
Data from a new phase 3 study demonstrated that once-daily Victoza® (liraglutide [rDNA origin] injection) provided greater glycaemic control versus placebo with no worsening of renal function in adults with type 2 diabetes and moderate renal impairment.1,2 The data were presented today at the 74th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA. Renal impairment is one of the more challenging and common long-term complications of diabetes and limits the use of available antidiabetic treatment options.3
The 26-week, double-blind, randomized, controlled study investigated the efficacy and safety of Victoza® compared with placebo when added to preexisting oral antidiabetic treatment, insulin or a combination thereof. The study showed that adults with type 2 diabetes and moderate renal impairment, defined as those with stage 3 chronic kidney disease (eGFR 30-59 mL/min/1.73 m2; MDRD), treated with Victoza® had significantly greater improvements in mean HbA1c (a measure of blood glucose levels) (-1.05% vs. -0.38%; ETD -0.66% [95% CI: -0.90;-0.43]; p<0.0001), were more likely to achieve target HbA1c <7% (52.8% vs. 19.5%; p<0.0001), and experienced significantly greater weight loss from baseline (-2.41 kg/5.31 lbs vs. -1.09 kg/2.40 lbs; ETD -1.32 kg/2.90 lbs [95% CI: -2.24;-0.40]; p=0.0052) versus placebo. No worsening of renal function and a lower incidence of hypoglycaemia with treatment of Victoza® compared with placebo were observed in the study.1, 2
"Renal impairment is very common in patients with type 2 diabetes, especially in adults over 65 years of age," said Melanie Davies, Professor of Diabetes Medicine and Honorary Consultant, Diabetes Research Centre, University of Leicester, U.K. "Of the therapies available for type 2 diabetes, it is essential we have treatment options for patients with associated renal impairment."
Overall, there is limited experience with Victoza® (liraglutide [rDNA origin] injection) in patients with mild, moderate, and severe renal impairment, including end-stage renal disease. Victoza® should be used with caution in this patient population.
The most common adverse events (AEs) seen in this study were gastrointestinal. These included nausea (21.4% vs. 4.4% placebo), vomiting (12.1% vs. 2.2%), diarrhoea (7.1% vs. 2.9%) and constipation (5.7% vs. 1.5%). Additional frequent AEs (≥5%) were renal impairment (5% vs. 5.8% placebo), nasopharyngitis, usually referred to as the common cold (5% vs. 11.7%), headache (5% vs. 2.9%), increased lipase (15% vs. 8.8%) and decreased glomerular filtration rate (6.4% vs. 5.1%).
About the study
The phase 3 study was a multinational study involving 277 adults. People with moderate renal impairment were defined as those with stage 3 chronic kidney disease. Participants were randomised to either Victoza® 1.8 mg, the highest dosage available, or placebo as add-on to existing oral antidiabetic treatment and/or insulin therapy. The mean age of participants was 68 years old and 66.3 for people treated with Victoza® or placebo, respectively. The primary endpoint was percentage change in HbA1c from baseline. Other endpoints included HbA1c to target <7% and body weight change from baseline. Renal function was measured by estimated glomerular filtration rate (eGFR) change from baseline.
Victoza® is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
As of January 2014, Victoza® has been commercially launched in 68 countries globally including the U.S., Canada, Japan, U.K., Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia, and China, as well as a number of other countries, and will be available in other markets throughout 2014.