Date: 2015-08-26
Type of information: Results
phase: 3
Announcement: results
Company: Novo Nordisk (Denmark)
Product: Victoza® (liraglutide)
Action
mechanism: Glucagon-like Peptide 1 (GLP-1) analogue. Victoza® is a human glucagon-like peptide-1 (GLP-1) analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and to suppress glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Israel, The Netherlands, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Ukraine, UK, USA
Trial
details: 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 TWO (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. This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes. (NCT02098395)
ADJUNCT ONE (1,398 people randomised) - a 52-week, double-blind, placebo-controlled treat-to-target trial investigating liraglutide as adjunct to insulin therapy. This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks. (NCT01836523)
Latest
news: * On August 26, 2015, Novo Nordisk 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 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. 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.
