Novo Nordisk completes second and final phase 3a trial with liraglutide as adjunct therapy to insulin for people with type 1 diabetes (NN9211)

Bagsværd, Denmark, 24 August 2015 - Novo Nordisk today announced headline results from the second and final phase 3a trial with liraglutide as adjunct therapy to insulin for people with type 1 diabetes. ADJUNCT ONE(TM) is a randomised, double-blind, placebo-controlled trial investigating efficacy and safety of daily doses of 0.6 mg, 1.2 mg and 1.8 mg liraglutide compared with placebo as adjunct to insulin treatment. 1,398 people with type 1 diabetes were treated for 52 weeks.

From a mean baseline HbA_1c of around 8.2%, people treated with 1.2 mg and 1.8 mg liraglutide as adjunct to insulin therapy achieved the primary objective of non-inferiority in HbA_1c and showed a greater improvement in HbA_1c of around 0.5% compared with 0.3% for people treated with placebo. The primary objective of HbA_1c non-inferiority was not confirmed for the 0.6 mg dose.

Furthermore, from a mean baseline weight of around 86 kg, people treated with 1.2 mg and 1.8 mg liraglutide as adjunct to insulin therapy achieved a statistically significantly greater weight loss between 3 kg and 4 kg whereas people treated with placebo experienced a weight gain of around 1 kg.

In the trial, the most common adverse events were related to the gastrointestinal system, primarily transient nausea and vomiting. The rate of severe hypoglycaemia appeared numerically, but not statistically significantly lower for all doses of liraglutide as adjunct to insulin therapy compared with placebo. A statistically significant higher rate of confirmed symptomatic hypoglycaemia was observed among people treated with liraglutide 1.2 mg and 1.8 mg compared with people treated with placebo. The proportion of people with serious adverse events was similar in all treatment groups.

Based on a risk/benefit assessment of the overall dataset from the two ADJUNCT trials, Novo Nordisk does currently not intend to submit an application to expand the label of Victoza^® for use in type 1 diabetes. Novo Nordisk intends to conduct thorough analyses to evaluate the clinical data and define potential future clinical and regulatory initiatives.   

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

Liraglutide is a once-daily human analogue of the naturally occurring hormone Glucagon-Like Peptide-1 (GLP-1). The compound is approved for the treatment of type 2 diabetes, and is currently in phase 3 development for the treatment of type 1 diabetes as adjunct to insulin therapy. Liraglutide works by stimulating the release of insulin only when glucose levels become too high, supressing 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 ADJUNCT programme is a phase 3 clinical programme comprising two global trials of liraglutide as adjunct to insulin therapy encompassing more than 2,000 people with type 1 diabetes.

ADJUNCT ONE(TM) (1,398 people randomised) - a 52-week, double-blind, placebo-controlled treat-to-target trial investigating liraglutide as adjunct to insulin therapy. 

ADJUNCT TWO(TM) (835 people randomised) - a 26-week, double-blind, insulin-capped, placebo-controlled trial investigating the additional glucose control of liraglutide as adjunct to insulin therapy. The results were announced on 6 August 2015.

Further information

Company announcement No 51 / 2015