Date: 2011-12-06
Type of information: Results
phase: 3
Announcement: results
Company: Sanofi (France)
Product: Lyxumia® (lixisenatide) in combination with Lantus® (insulin glargine)
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.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: The GetGoal phase III clinical program provides data for lixisenatide in adults with type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal program started in May 2008 and has enrolled more than 4,500 patients. To date, GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono, GetGoal-S, GetGoal-F1 and GetGoal Duo1 (also known as EFC10781*) have reported positive top-line results supporting potential efficacy and safety for lixisenatide. Further results are expected in 2012.
Latest news: Sanofi has announced that Lyxumia® (lixisenatide), its investigational GLP-1 agonist, in combination with Lantus® (insulin glargine) achieved its primary efficacy endpoint of significantly reducing HbA1c, with a significant improvement in post-prandial glucose, in the GetGoal Duo 1 study (also known as EFC10781*). Positive topline results of GetGoal Duo1 demonstrated the efficacy and safety of lixisenatide in combination with insulin glargine in patients with type 2 diabetes uncontrolled on oral anti-diabetics (OADs) – mainly metformin. This randomized, double-blind, placebo-controlled study included a 12-week run-in period with insulin glargine initiated and titrated to reach a target fasting plasma glucose of 80-100 mg/dL followed by a 24-week randomized period where 446 patients with HbA1c >7% - despite controlled fasting plasma glucose - received either lixisenatide once-daily or placebo while insulin glargine and metformin were continued. 88% of patients in the lixisenatide arm reached and remained on the 20 ?g maintenance dose. During the run-in period, HbA1c decreased on average from 8.60% to 7.60%. After randomization the addition of lixisenatide led to a further significantly greater HbA1c decrease compared with placebo (p<0.0001) to a mean value of 6.96% after 24 weeks with a significantly higher percentage of patients achieving target HbA1c <7.0% with lixisenatide vs. placebo (56.3% vs. 38.5%, respectively, p=0.0001). Lixisenatide also significantly improved 2-h post-prandial glucose with a mean difference of -3.16 mmol/L (p<0.0001) vs placebo. The mean difference in change in body weight between the lixisenatide and placebo groups was -0.89 kg (p=0.0012). Consistent with the GLP-1 class, the most common adverse events were mild and transient nausea and vomiting. Fifty (22.4%) lixisenatide-treated patients and 30 (13.5%) patients in the placebo group reported symptomatic hypoglycemic events as defined in the protocol during the on-treatment period. The full study results from GetGoal Duo 1 are planned to be presented at a future medical congress. On November 16th, 2011, the European Medicines Agency (EMA) accepted Sanofi’s marketing authorization application filed for Lyxumia® (lixisenatide). Submission for regulatory approval of lixisenatide in the U.S. is expected in Q4 2012.
