Sanofi’s experimental insulin U300 equivalent to Lantus in Phase III trials

Sanofi announced data from two separate Phase III studies demonstrating that its investigational new insulin U300 showed equivalent glycated hemoglobin (HbA1C) control with fewer night-time hypoglycaemia events compared to Lantus (insulin glargine). Pierre Chancel, Senior Vice President of Global Diabetes at Sanofi noted that "with the investigational new insulin U300, we are striving to further enhance the clinical value of basal insulin, while building on the wealth of evidence of Lantus."

The EDITION I trial, data from which were presented at the American Diabetes Association annual meeting, randomised 807 patients with type 2 diabetes using basal plus mealtime insulin to receive either U300 or Lantus once daily in the evening while continuing mealtime insulin. Data showed that U300 achieved similar reductions in HbA1C from baseline compared to Lantus at 6 months. In addition, approximately 40 percent of study participants with uncontrolled glycaemic levels despite receiving a combined therapy of oral antidiabetic agents plus basal and prandial insulins reached glycemic control at month 6 both in the U300 and in the Lantus arm. Further, the occurrence of any nocturnal hypoglycemic event during the 6-month study period was 45.3 percent in the U300 arm, compared to 59.7 percent in the comparator arm. Sanofi noted that U300 was well-tolerated in this study, with no differences in other adverse events observed from Lantus.

Data from the trial also showed that 36.1 percent of patients in the U300 arm had nocturnal hypoglycaemia during months 3 to 6, compared to 46.0 percent of patients given Lantus, a difference that was considered statistically significant. Further, the occurrence of any nocturnal hypoglycemic event during the 6-month study period was 45.3 percent in the U300 arm, compared to 59.7 percent in the comparator arm. Sanofi noted that U300 was well-tolerated in this study, with no differences in other adverse events observed from Lantus.

Meanwhile, topline results from the EDITION II trial, which included 811 patients treated with basal insulin plus oral antidiabetic therapy, were consistent with those observed in the EDITION I trial, Sanofi announced. The drugmaker indicated that results of the EDITION II study will be presented at an upcoming scientific meeting, with full results from both trials expected by the end of the year.

Chancel noted that if results from the EDITION trials are confirmed, U300 will be a "better tool" than Lantus, which last year garnered just under 5 billion euros ($6.5 billion) in sales and is scheduled to lose patent protection in 2015. Chancel added that U300 "would retain the value of glargine," including its safety profile, while offering "other interesting features," such as a lower risk of night-time hypoglycemia. Analysts suggest that U300 could launch as early as 2014 and generate as much as $974 million by 2018. U300 "should allow Sanofi to defend its position in the diabetes space," Exane BNP Paribas analyst Vincent Meunier noted, adding that "it’s good news for them." Bryan Garnier & Co. analyst Eric Le Berrigaud added that U300 " has to be seen as the first line of defense for Lantus."

For further analysis on Sanofi’s efforts in the diabetes market, please read ViewPoints: Sanofi sees no conflict in marketing biosimilar insulins alongside branded Lantus

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