Date: 2014-09-19
Type of
information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD)
Company: Sanofi (France) Zealand Pharma (Denmark)
Product: LixiLan® (single injection Lyxumia®(lixisenatide) /Lantus® (basal insuline) combination product
Action
mechanism: GLP-1 agonist/peptide/insulin analogue. 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.
Lantus® (insulin glargine) is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Disease: type 2 diabetes
Therapeutic
area: Metabolic diseases
Country:
Trial
details:
- • On 19 September 2014, Zealand Pharma provides a summary of new clinical data presented on Lixilan® 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.
- On LixiLan, the fixed-ratio combination of Lyxumia® and Lantus®, currently in Phase III development by Sanofi, new data from the completed Phase IIb trial (323 patients) was presented orally by Dr. Julio Rosenstock (Abstract # 241) under the headline “Benefits of a fixed-ratio formulation of once-daily insulin glargine/lixisenatide (LixiLan) vs glargine in type 2 diabetes inadequately controlled on metformin.” (J. Rosenstock et al.).
- The results presented show that LixiLan achieved robust HbA1c reductions to 6.3% with weight loss (-1.0 kg from baseline and -1.4 kg vs Lantus®) and no increased hypoglycaemia vs Lantus®, with very low gastrointestinal adverse events in type 2 diabetes patients inadequately controlled on metformin. Sanofi has previously confirmed the planned completion of Phase III development of LixiLan in H2 2015 and with a subsequent US regulatory filing expected as early as end 2015.
Latest
news:
- • On November 21, 2014, Sanofi provided a summary of results from the Phase IIb proof-of-concept study in 323 patients with Type 2 diabetes, presented on at ADA and at EASD earlier in 2014. Results from the study show that LixiLan gave a robust reduction in HbA1c (three months blood sugar level) from 8.1% to 6.3% with 84% of the patients on LixiLan having achieved the HbA1c target of <7%. Patients treated with LixiLan also had a reduction in body weight (-1kg) and experienced less frequent nausea and vomiting compared to what has been reported for the GLP-1 class and a low incidence rate of symptomatic hypoglycemia.
Is
general: Yes
