In the DELIVER 2 study, after six months, patients who switched to Toujeo experienced
33 per cent fewer hypoglycemic events versus those who switched to other basal insulins, without compromising blood sugar control
Sanofi announced the presentation of a new observational study1 in real-world clinical practice demonstrating significantly lower risk of hypoglycemia without compromising blood sugar control in patients with type II 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, US.
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) analysed 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 per cent fewer hypoglycemic events (event rate per 100 patient-months: 5.32 vs. 7.98, 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 per cent reduction in hypoglycemic events related to inpatient or ED encounters (event rate per 100 patient-months: 1.97 vs. 3.82, respectively; p<0.01) versus other basal insulins.
“With these DELIVER 1 and 2 studies conducted in a real-world setting, we see treatment with Toujeo leading to less hypoglycemia without compromising blood glucose control,” said Lawrence Blonde, MD, Director of the Ochsner Diabetes Clinical Research Unit, in the Frank Riddick Diabetes Institute at the Ochsner Medical Center-Jefferson Highway, New Orleans, LA, US and a co-author of DELIVER 2. “Of particular importance is the lower observed rate of hypoglycemic events related to inpatient or emergency department encounters.”
“Hospital visits are a major contributor to the overall cost of care for people with diabetes, so the lower rate of related hypoglycemic events is particularly interesting. These consistent results increase the body of evidence on the use of Toujeo in people with type II diabetes from observational studies. While randomised clinical trials provide the highest level of evidence, comparative data from real-world observational studies can be relevant for payors and other organisations 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 randomised Real Life Study programme 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 programme of Phase 3 clinical trials, Sanofi is conducting a programme, unique in diabetes, of three randomised, 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 II diabetes across the US 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 utilisation. Initial results are anticipated later in 2017.
The DELIVER 2 retrospective observational study used data from the Predictive Health Intelligence Environment (PHIE) database of US real-world electronic medical records (representing 26 integrated health delivery networks). Included patients were adults with type II diabetes using basal insulin, with data for 12 months prior to (baseline) and 6 months after (follow-up) switching to either Toujeo or other basal insulins. The study used a matched cohort model, based on baseline demographics and clinical characteristics, and analysed outcomes for 947 patients who switched to Toujeo alongside 947 who switched to other basal insulins (insulin glargine 100 Units/mL, insulin detemir or insulin degludec). Outcome assessments included reduction in HbA1c from baseline, HbA1c goal attainment (<7.0 per cent and <8.0 per cent) and incidence and event rate of hypoglycemia (identified by ICD-9-CM/ICD-10-CM and/or plasma glucose level = 70 mg/dL).
These findings represent actual prescribing patterns and clinical outcomes outside the confines of a clinical trial, which might include drug use outside FDA-approved prescribing information. As a result, reporting of hypoglycemia at baseline and in both treatment arms were not based on self-monitored blood glucose, which could result in less severe events not being reported by patients.
Mean baseline HbA1c was 8.89 per cent in the Toujeo cohort and 8.91 per cent in the other basal insulin cohort, and levels decreased significantly to 8.42 per cent and 8.50 per cent, respectively, during the six-month follow-up period (p<0.01 for both).
After six months, patients who switched to Toujeo experienced 33 per cent fewer hypoglycemic events (event rate per 100 patient-months: 5.32 vs. 7.98, respectively; p<0.01) versus those who switched to other basal insulins (difference: -2.67 events per 100 patient-months; p<0.01)
A similar trend was observed for hypoglycemia related to inpatient or emergency department (ED) encounters (event rate per 100 patient-months: 1.97 vs. 3.82, respectively; p<0.01).
Significantly lower hypoglycemia risk was also seen at three months of follow-up among patients who switched to Toujeo.
1. Zhou FL et al, Lower Risk of Hypoglycemia after Switch to Insulin Glargine 300 U/Ml (Gla-300) Vs Other Basal Insulins in Patients with Type II Diabetes (T2D) on Basal Insulin in Real-World Clinical Settings (DELIVER 2 study), Poster presentation LB SUN 81, Endocrine Society 2017 Annual Meeting [ENDO 2017], Orlando, FL, US.
2. Ye, F et al, Real-World Assessment of Patient Characteristics and Clinical Outcomes of Early Users of the New Insulin Glargine 300U/mL, Poster presentation 943-P, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, US Saturday, June 11, 2016.