Lixisenatide scores in phase III trial
pharmafile | April 15, 2010 | News story | Research and Development | GLP-1, Lixisenatide, diabetes
Sanofi-Aventis’ novel, once-daily diabetes treatment lixisenatide has successfully met its phase III glucose blood level and glycaemic control endpoints.
The placebo-controlled study of the GetGoal phase III trial showed that lixisenatide (AVE0010) helped patients achieve HbA1c (glucose blood level) of less-than 7%, and improved glycaemic control in adult patients with type II diabetes.
The 12-week study of the glucagon-like peptide (GLP-1) receptor agonist involved 361 patients with type II diabetes not currently receiving glucose-lowering therapy and with HbA1c between 7 and 10 percent.
HbA1c was significantly reduced in both lixisenatide titration groups versus placebo, and significantly more patients in the lixisenatide groups achieved HbA1c at less-than 7% (46.5 to 52.2% versus 26.8%) as compared to placebo.
Lixisenatide also significantly improved fasting plasma glucose levels and two-hours after-eating with a pronounced decrease in the latter.
Lixisenatide was generally well tolerated with the most common adverse event being, as Sanofi expected with this class of drugs, nausea occurring in 20 to 24% of lixisenatide-treated patients and 4% of placebo patients. The incidence of symptomatic hypoglycemia (insulin shock) was low at 1.7% and similar in the lixisenatide and placebo groups.
Dr Marc Cluzel, executive vice-president of R&D at Sanofi-Aventis, said: “We are pleased with the top-line results from our first Phase III study of this novel, once-daily GLP-1 agonist and are looking forward to sharing the full results later in the year.”
Complete trial data will be shown at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASL) in Stockholm, in September 2010.
GLP-1 receptor agonists such as lixisenatide normalise elevated blood sugar by enhancing insulin secretion until blood sugar levels approach normal concentration. This mode of action combines high anti-diabetic efficacy with low-risk of hypoglycemia.
Lixisenatide will have to compete with both Amylin/Lilly’s Byetta LAR (exenatide) and Novo Nordisk’s Victoza (liraglutide) that both use GLP-1 processes. Both have been beset by problem in recent months with Victoza showing pancreatitis concerns after approval and Byetta LAR being questioned over manufacturing concerns by the FDA.
Lixisenatide was out-licensed to Sanofi in 2003 by Danish-based Zealand Pharma who is now responsible for all further clinical development. Sanofi is hoping to move to phase III clinical trials for a combination of its recombinant human insulin Lantus (insulin glargine) and lixisenatide later this year.
Last week Sanofi announced the collaboration with CureDM for Pancreate that has the potential to ‘reverse’ the disease.
Related Content
MetP Pharma releases positive data on intranasal semaglutide administration
MetP Pharma has released new data highlighting the advantages of its MetP technology in delivering …
AOTI diabetic foot care therapy to be used by NHS
Effective from September 2025, AOTI’s Topical Wound Oxygen (TWO2) therapy has been awarded inclusion in …
Recce Pharmaceuticals reports positive phase 2 data for skin infection drug
Recce Pharmaceuticals have announced positive patient data from its phase 2 clinical trial into RECCE …
