August 27, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BAGSVAERD, Denmark – Novo Nordisk , the world’s largest insulin maker, will not pursue an expansion of Victoza (liraglutide) for use in type 1 diabetes after disappointing Phase III trial results, the company announced this week.
Victoza is a GLP-1 analogue used to treat type 2 diabetes. In the latest study, dubbed Adjunct One, Victoza (liraglutide) combined with an insulin improved blood glucose control in attempts to treat type 1 diabetes actually worsened episodes of low blood sugar, the company reported.
For one year 1,400-person trial patients were treated with daily doses of three strengths of the Victoza combination at 0.6 mg, 1.2 mg and 1.8 mg, or a placebo. Patients treated with the higher doses of the combination reduced HbA1c and also assisted in greater weight loss than placebo. However, the .6 mg dosage had results lower than the placebo group, the company said. The rate of severe hypoglycemia was not statistically lower than the placebo group for patients treated with all three dosage levels.
Mads Krogsgaard Thomsen, Novo Nordisk’ chief science officer, said the drug did succeed in improving blood glucose control and weight loss, but the drug did not provide the same hypoglycemic benefit experienced in type 2 diabetes.
After reviewing the data, Novo Nordisk said based on the “risk/ benefit assessment of the overall dataset” the company did not intend to pursue expanding the use of Victoza for type 1 diabetes.
“We are disappointed as we believed in the potential to provide people with type 1 diabetes with a new treatment option, and we will continue to invest in new treatment options for this group of people,” Thomsen said in a statement.
Victoza works by stimulating the release of insulin only when glucose levels become too high, suppressing the glucagon production by the liver and by inhibiting appetite. In contrast to most other antidiabetic treatments, liraglutide also leads to weight loss instead of weight increase.
The failure of Victoza as a treatment for type 1 diabetes came at the same time the company is moving the long-acting GLP-1 analogue semaglutide, for the treatment of type 2 diabetes, into a Phase III trial. The oral treatment will be given to approximately 8,000 patients in the trial, the company said.
In April, Novo Nordisk announced its Saxend, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults, was available for sale in the United States. Obese individuals often develop type 2 diabetes.
Novo Nordisk manufactures a number of diabetes treatments, including Victoza, NovoLog and Levemir. Earlier this year, the company said it plans on ramping up production of insulin to more than double its current output as more and more diagnoses of diabetes are made. In 2012, nearly 10 percent of the U.S. population had been diagnosed with some form of diabetes, according to the American Diabetes Association. Type 2 diabetes is on the rise in the United States, driven partly by the increase in the waistlines of Americans. A 2014 study published in the Annals of Internal Medicine showed a steady increase in diagnoses of the disease over the past decade.
To support the increase in insulin manufacturing, Novo Nordisk announced on Aug. 26 the company would invest up to $2 billion to build a new manufacturing facility in Johnston County, N.C.
