Observational Study Finds Sanofi’s Diabetes Drug Lowers Incidence of Hypoglycemia

Data from a recent real-world observational study has found that that Sanofi’s type 2 diabetes drug, Toujeo (insulin glargine 300 Units/mL), was associated with a lower risk of hypoglycemia, compared to other basal insulins. According to the researchers – who presented at the Endocrine Society 2017 Annual Meeting – diabetic patients taking Toujeo experienced fewer hypoglycemic events, without loss of blood sugar control.

The observational study – DELIVER 1 – analyzed the electronic medical records for nearly 1,900 type 2 diabetic patients. For the purposes of comparative analysis, patients were equally split into two cohorts: patients that switched from basal insulin to Toujeo, and patients that switched from one basal insulin to another.

Using data collected one year before the medication switch, and six months after, the researchers compared the average change in blood sugar levels, occurrence of hypoglycemia, and the incidence of hypoglycemia-related inpatient or emergency room visits. Diabetic patients who switched from basal insulin to Toujeo showed fewer hypoglycemic events, compared those who switched to another basal insulin.

What’s more, the reduced rate of hypoglycemic events was not associated with a compromise in blood sugar control in patients taking Toujeo. Patients taking Toujeo also experienced a nearly 50 percent reduction in inpatient or emergency room visits associated with hypoglycemic events.

“These results increase the body of evidence on the use of Toujeo in people with type 2 diabetes from observational studies,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, ‎Sanofi. “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.”

Toujeo was approved by the US Food and Drug Administration (FDA) over two years ago, in February of 2015. In the fourth quarter of 2016, Toujeo sales totaled €238 million, with €169 million generated in the US market alone.

“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,” said Perfetti. “The randomized Real Life Study program will provide further evidence that directly reflects Toujeo’s performance in standard clinical practice.”