Sanofi announced the presentation of a new observational study in real-world clinical practice demonstrating significantly lower risk of hypoglycemia without compromising blood sugar control in patients with type 2 diabetes (T2D) using basal insulin who switched to Toujeo (insulin glargine 300 Units/mL) when compared to other basal insulins. The results of the study were presented at the Endocrine Society 2017 Annual Meeting (ENDO 2017) in Orlando, FL, U.S.
A previous real-world observational study2 (DELIVER 1) assessed the change in HbA1c (average blood sugar levels) and occurrence of hypoglycemia in 881 patients, based on electronic medical records up to six months after switching to Toujeo from another basal insulin. This new observational study (DELIVER 2) analyzed electronic medical records for 1,894 patients in two matched cohorts. The comparative study assessed the HbA1c change, occurrence of hypoglycemia (identified by ICD-9-CM/ICD-10-CM and/or plasma glucose level ≤ 70 mg/dL) and hypoglycemic events related to inpatient or emergency department (ED) visits with Toujeo versus other basal insulins (insulin glargine 100 Units/mL, insulin detemir and insulin degludec).
In the DELIVER 2 study, after six months, patients who switched to Toujeo experienced 33 percent fewer hypoglycemic events (event rate per 100 patients-months: 7.98 vs 5.32, respectively; p<0.01) versus those who switched to other basal insulins, without compromising blood sugar control. In addition, patients who switched to Toujeo showed a 48 percent reduction in hypoglycemic events related to inpatient or ED encounters (event rate: 3.82 of patients vs 1.97, respectively; p<0.01) versus other basal insulins.
“These results increase the body of evidence on the use of Toujeo in people with type 2 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,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. “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.”
Complementing these observational studies in routine clinical practice and the EDITION program of Phase 3 clinical trials, Sanofi is conducting a program, unique in diabetes, of three randomized, prospective real-life clinical studies with Toujeo. These studies, called ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL, involve more than 4,500 people with type 2 diabetes across the U.S. and Europe who are starting basal insulin treatment or switching from another basal insulin. In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with impact on healthcare resource utilization. Initial results are anticipated later in 2017.
Filed Under: Drug Discovery
