PARIS, September 13, 2016 /PRNewswire/ --
- Benefits on adherence and HbA1c to be validated in
a real-world setting -
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.
About Toujeo®
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.
About Sanofi
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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