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Victoza will not be expanded for type 1 diabetes use

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Novo Nordisk does not intend to submit an application to expand the label of Victoza for use in type 1 diabetes, following phase 3a trial results that showed a significantly higher rate of hypoglycemia in adults assigned the drug compared with those assigned a placebo.

"The results of the two ADJUNCT trials show that liraglutide as adjunct to insulin therapy met the primary endpoint of improving blood glucose control for people with type 1 diabetes, however, unfortunately without the hypoglycemic benefit experienced in type 2 diabetes,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in a statement. "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."

ADJUNCT ONE is a randomized, double-blind, placebo-controlled trial investigating efficacy and safety of daily doses of 0.6 mg, 1.2 mg and 1.8 mg of Victoza (liraglutide) compared with placebo as an adjunct to insulin treatment. The cohort included 1,398 adults with type 1 diabetes treated for 52 weeks.

Adults with a mean baseline HbA1c of 8.2% assigned 1.2 mg and 1.8 mg of liraglutide as adjunct to insulin therapy achieved the primary objective of non-inferiority in HbA1c, according to researchers, and showed an average 0.5% improvement in HbA1c, compared with 0.3% for adults assigned placebo. The primary objective of HbA1c noninferiority was not confirmed for the 0.6 mg dose.

Participants assigned 1.2 mg and 1.8 mg of liraglutide also experienced significantly greater weight loss (between 3 kg and 4 kg) compared with those assigned placebo, who gained an average of 1 kg.

However, a statistically significant higher rate of confirmed symptomatic hypoglycemia was observed among adults assigned 1.2 mg and 1.8 mg liraglutide compared with adults assigned placebo. The proportion of people with serious adverse events — mostly transient nausea and vomiting — was similar in all treatment groups.

The company announced in a press release that it will conduct a thorough analysis to evaluate the clinical data and define potential future clinical and regulatory initiatives.