Novo Nordisk's new long-acting insulin Tresiba has been shown to be effective and safe for long-term use in children and young adults with Type 1 diabetes, according to new data from a late-stage trial presented on Tuesday.
Long-acting Tresiba is an important product for future growth at the company, which is the world's top insulin maker.
U.S. regulators have refused to approve Tresiba due to potential heart risks, dealing a blow to the company. Tresiba was approved in the European Union last year.
Results of the first trial to look at the long-term safety of Tresiba in children aged one to 18 years over a 52-week period showed it improved blood sugar control without increasing the risk of hypoglycaemia, or dangerously low sugar levels.
Tresiba also helped more patients achieve a significantly greater reduction in the fasting plasma glucose, the concentration of glucose in plasma measured after the patient has not eaten for at least eight hours, the company said.
The new data from the study, unveiled at a meeting of the European Association for the Study of Diabetes (EASD) in Vienna, is the first of its kind conducted by Novo Nordisk.
In the study, which included 350 patients diagnosed with Type 1 diabetes, also known as juvenile diabetes, Tresiba was compared with Novo's older insulin Levemir. Both Tresiba and Levemir were combined in the study with Novo's mealtime insulin aspart, also known as NovoRapid in Europe.
"These data show that Tresiba has the potential to offer youngsters with diabetes a new treatment option, which may help them achieve better control of their diabetes," Dr. Nandu Thalange of Norfolk and Norwich University Hospital in Britain. He is one of the lead investigators.
About 29 million Americans and an estimated 382 million people worldwide have Type 1 or 2 diabetes, a chronic condition that occurs when the body does not properly produce or use the hormone insulin.
The World Health Organization estimates that about 10 percent of the 382 million people in the world with diabetes have the Type 1 variant - most have type 2, which is caused as the body slowly stops responding to insulin, associated with obesity and lack of exercise.
Mostly children and young adults have Type 1 diabetes where the body does not make insulin.