– Benefits on adherence and HbA1c to be validated in a real-world setting –
Paris, France – September 13, 2016 – Sanofi announced today that adults with type 2 diabetes treated with Toujeo® (insulin glargine 300 Units/mL) experienced a consistently lower rate of confirmed or severe hypoglycemia both at night and at any time of the day compared with those treated with Lantus® (insulin glargine 100 Units/mL), at all levels of HbA1c (average blood glucose over the previous three months) achieved at month 6. The results of this new patient-level meta-analysis from the EDITION 1, 2 and 3 Phase 3 clinical trials in patients with type 2 diabetes were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.
“For people with diabetes, it is vital to achieve good glycemic control in order to minimize the risk of microvascular complications. Risk of hypoglycemia can be an important factor in the person as well as their treating physician’s attitude towards treatment of their diabetes, and can lead to improved adherence and reduced glycemic control in real-world conditions,” said Pratik Choudhary, Senior Lecturer and Consultant in Diabetes, Kings College London, UK and lead author of the presentation. “These results show that in more than 2,000 patients that Toujeo could enable adults with type 2 diabetes to achieve equivalent glycemic control with less hypoglycemia vs. Lantus. We look forward to the validation of these important findings in real-world settings.”
In addition, the first clinical evidence in a real life setting to reflect the possibility of achieving glycemic control with fewer hypoglycemic events was presented at the American Diabetes Association (ADA) 76th Scientific Sessions. Those data were drawn from existing patient-level information (from the Predictive Health Intelligence Environment database) on patients switching to Toujeo from other basal insulins under real-life conditions. The results demonstrated that patients treated with Toujeo experienced a mean estimated reduction in HbA1c of 0.64% (p<0.0001) after 6 months of treatment, while the occurrence of hypoglycemia was 6.0% at baseline and 5.1% at follow-up.
“These encouraging meta-analysis findings, in combination with preliminary patient-level data from a real-life setting, provide useful information about Toujeo’s potential to help people with diabetes achieve better glycemic control without additional risk of hypoglycemia,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. “We are currently conducting a broad real-world clinical program to confirm these findings.”
Sanofi is conducting three large, randomized clinical trials – ACHIEVE, REACH and REGAIN CONTROL – evaluating in real-life conditions the effect of Toujeo in people with type 2 diabetes. These trials will provide an important evaluation of the effectiveness of Toujeo’s disease-management strategy, that could be particularly relevant to healthcare professionals, diabetes educators and payers.
About EASD abstract
The meta-analysis was performed on patient-level data from the EDITION 1, 2 and 3 phase 3 clinical trials (n=2,103). Annualized rate of confirmed (≤3.9 mmol/L or ≤70.2 mg/dL) or severe hypoglycemia rate (events per participant-year) was correlated with HbA1c data at month 6 for each patient, using a negative binomial regression model. There was no overlap between the curves for Toujeo® (insulin glargine 300 Units/mL) and Lantus® (insulin glargine 100 Units/mL), demonstrating that the hypoglycemia rate was lower with Toujeo® than with Lantus® at all levels of HbA1c.
The presentation is titled: “Hypoglycaemia as a function of HbA1c in type 2 diabetes (T2DM): insulin glargine 300 U/ml in a patient-level meta-analysis of EDITION 1, 2 and 3” (Choudhary P, et al. Oral presentation #10, European Association for the Study of Diabetes (EASD) 52nd Annual Meeting, Munich, Germany, September 13, 2016).
About patient-level information from the PHIE database
Adults with type 2 diabetes who had used other basal insulins within the 6 months prior to Toujeo initiation (one or more prescription orders of Toujeo® between March 2015 and December 2015) were identified. The PHIE records of those identified (n=881) were assessed for HbA1c and incidence of confirmed (≤3.9 mmol/L or ≤70.2 mg/dL) or severe hypoglycemia up to 6 months prior to and up to 6 months after initiation.
Among the subpopulation of patients (n=267) with HbA1c measured at baseline and during follow-up (0-6 months), mean HbA1c was 8.97% at baseline and 8.33% at follow-up. For the subpopulation of patients (n=449) with occurrence of hypoglycemia reported at baseline and during follow-up (0-3 months), this was 6.0% at baseline and 5.1% at follow-up.
The poster is titled “Real-World Assessment of Patient Characteristics and Clinical Outcomes of Early Users of the New Insulin Glargine 300U/mL” (Ye F, et al. Poster presentation 943-P, New Orleans, LA, U.S., Saturday, June 11, 2016).
About ACHIEVE, REACH and REGAIN CONTROL
The ACHIEVE CONTROL study will evaluate the effect of Toujeo® versus other basal insulins in a real-life setting on achieving individualized glycemic targets without hypoglycemia at any time of day in 3,270 uncontrolled insulin-naïve people in the U.S. with type 2 diabetes.
The REACH CONTROL will follow 920 insulin-naïve people with type 2 diabetes in Europe, comparing HbA1c change with Toujeo® versus other basal insulins, alongside incidence of hypoglycemia, change in body weight, and measures of persistence with treatment and need for treatment intensification in a real-life setting.
The REGAIN CONTROL study will compare HbA1c reduction, incidence of hypoglycemia, change in body weight and persistence with treatment on Toujeo® versus other basal insulins in 800 people with type 2 diabetes in Europe, who are currently uncontrolled on basal insulin in a real-life setting. In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with healthcare resource utilization.
Toujeo® is a once-daily basal insulin based on a broadly-used molecule (insulin glargine). Toujeo has been approved by the U.S. Food and Drug Administration (FDA), the European Commission, Health Canada, the Therapeutic Goods Administration in Australia, and the MHLW in Japan (where its approved brand name is Lantus® XR), and is under review by other regulatory authorities around the world.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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