Date: 2014-09-19
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna
Company: Sanofi (France) Zealand Pharma (Denmark)
Product: Lyxumia® (lixisenatide)
Action
mechanism: GLP-1 agonist/peptide. Lixisenatide is a glucagon-like peptide-1 agonist (GLP-1). GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes.
Lyxumia® was invented by Zealand Pharma and licensed to Sanofi, which holds global commercial rights for the drug.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On 19 September 2014, Zealand Pharma provided a summary of new clinical data presented on Lyxumia® at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), which has taken place in Vienna, Austria on September 15-19, 2014 .Sanofi presented six abstracts on Lyxumia® (lixisenatide) at EASD, a once-daily prandial GLP-1 agonist, invented by Zealand and approved and marketed in several countries ex-US by Sanofi. The presentations on Lyxumia® included an oral presentation entitled “Impact of baseline gastric emptying on effects of lixisenatide and liraglutide in type 2 diabetes mellitus (T2DM) as an add-on to insulin glargine.” (Menge et al.). Sanofi also announced the recent initiation of the INTENSE (Intensifying iNsulin Therapy in type 2 diabetes: lixisENatide or Standard of carE) trial, a new patient-centric non-interventional study of Lyxumia® compared to other forms of injectable insulin intensification therapies, including short acting insulin. INTENSE, which is being initiated in several European countries, has a prospective recruitment of 2,400 adults with Type 2 diabetes, and will assess the safety and efficacy of adding injectable therapies to basal insulin, as well as the factors predicting the effectiveness of this intensification of treatment in a real-world standard of care setting. INTENSE will follow patients to also examine the ways real-life circumstances can impact patients’ perceptions, their ability to manage diabetes and their adherence to treatment. The first participant in this large-scale, post-approval observational study was enrolled at the end of July 2014 at Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Gran Canaria, Spain. Interim results will be available in 2015.
The presentation was on results of a further analysis from an 8-week head-to-head pharmacodynamic study of Lyxumia® versus liraglutide in patients optimally titrated with Lantus® (insulin glargine). The analysis showed that treatment with Lyxumia® delayed gastric emptying significantly more than treatment with liraglutide and that the effect correlated with a decrease in post-prandial (after-meal) blood glucose (PPG). Previously reported results from this study demonstrated a significantly greater reduction in PPG from baseline with Lyxumia® than with liraglutide.The new analysis also showed a less pronounced delay in gastric emptying within the Lyxumia® treatment group for patients who had slower gastric emptying at the start of treatment (baseline), suggesting a limited risk of aggravating pre-existing gastric emptying disturbances.
