Sanofi (NYSE:SNY) touted real-world clinical data for its Toujeo insulin glargine injection from a new observational study. The data from Deliver 2 showed that patients with Type II diabetes who switched to Toujeo from other basal insulins had significantly lower risk of hypoglycemia without compromising blood sugar control.
The Deliver 2 study analyzed electronic medical records for 1,894 patients in 2 matched cohorts, comparing changes to average blood sugar levels, as well as the rate of hypoglycemia and hypoglycemic events related to inpatient or emergency department visits in patients using Toujeo compared to other basal insulins.
After 6 months, patients who switched to Toujeo had 33% fewer hypoglycemic events compared to their cohorts, without compromising blood sugar control, Sanofi said. The company added that patients who switched to Toujeo had a 48% reduction in hypoglycemic events related to inpatient or emergency department encounters.
“These results increase the body of evidence on the use of Toujeo in people with Type II diabetes from observational studies. While randomized clinical trials provide the highest level of evidence, comparative data from real-world observational studies can be relevant for payors and other organizations evaluating how findings from clinical trials can translate into routine clinical practice,” Sanofi’s head of global diabetes Riccardo Perfetti said in prepared remarks. “Sanofi is committed to going beyond traditional models to conduct further studies to assess Toujeo, combining the broad populations, and type of interaction between healthcare professionals and patients seen in routine care with the rigorous methodology of clinical trials. The randomized Real Life Study program will provide further evidence that directly reflects Toujeo’s performance in standard clinical practice.”
Sanofi said it is conducting 3 randomized, real-life clinical studies with Toujeo, called Achieve Control, Reach Control and Regain Control. The studies enrolled more than 4,500 people with Type II diabetes who are starting basal insulin therapy or switching from a different basal insulin.
The researchers plan to collect patient feedback on treatment satisfaction, as well as clinical measures. The company expects initial results later this year, Sanofi reported.