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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