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 HbA1c 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 HbA1c and showed a greater improvement in HbA1c of around 0.5% compared with 0.3% for people treated with placebo. The primary objective of HbA1c 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.
- See more at: http://globenewswire.com/news-release/2015/08/24/762981/0/en/Novo-Nordisk-completes-second-and-final-phase-3a-trial-with-liraglutide-as-adjunct-therapy-to-insulin-for-people-with-type-1-diabetes-NN9211.html#sthash.a07qoJY9.dpuf