If you take Victoza to help control your blood sugar for type 2 diabetes, you can now officially wear the foam finger proclaiming your team is number one.
The FDA this week approved an expanded label for Victoza showing data from two large trials that compared Victoza head-to-head with Januvia®. In both studies, Victoza won 2-0 for superior blood sugar control and weight loss. (Published site)
Novo Nordisk announced the win for its once-daily injected drug in a press release. The approval allows the Victoza label to include data showing better blood sugar control and weight loss compared to Januvia.
The company’s Corporate Vice President for Diabetes Marketing Camille Lee is happy about the FDA’s action. “We’re pleased to expand the Victoza product label to include data demonstrating superior efficacy over Januvia,” Lee said. “The additional data supporting combination therapy with basal insulin further demonstrates that Victoza is an appropriate option for a wide variety of adults with type 2 diabetes.”
The two large studies showed that patients had an average reduction in blood sugar of 1.2 percent in one trial and 1.5 percent in the other compared to an average reduction of 0.9 percent in both trials for those taking Januvia.
When Victoza was added to treatment with metformin and Levemir (insulin) 43 percent of the patients achieved the American Diabetes Association target for blood sugar control of an HbA1c less than 7 percent after 26 weeks.
In addition, the people in the Victoza groups had an average weight loss of nearly 6 pounds in one trial and a little more than 7 pounds in the other trial compared to an average weight loss of 1.76 pounds for those taking Januvia. There were 665 people in one of the studies who took the drugs for six months, and 323 people took the drugs for that long in the other trial.
The most common side effect for the combination treatment of Victoza, metformin and insulin was diarrhea occurring in 11.7 percent in one trial and 6.9 percent in the other.
Despite its superior showing in weight loss, Victoza does not have FDA approval to sell the drug as a treatment for weight management. The weight loss results were obtained as a secondary aim of the studies.
Victoza, is the first human glucagon-like peptide-1 (GLP-1) drug that is 97 percent similar to natural human GLP-1. Like natural GLP-1, Victoza works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia.
There was no word on when Novo Nordisk might put Victoza’s once-daily treatment up against Amylin’s one-a-week Bydureon.
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