Sanofi Announces Positive Phase 3 Results for Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL) in Japanese People with Uncontrolled Diab
PR57068
Sanofi Announces Positive Phase 3 Results for Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL) in Japanese People with Uncontrolled Diabetes
PARIS, June 15/PRN=KYODO JBN/--
- In EDITION JP I and II, investigational Toujeo(R)demonstrated similar
blood sugar control with fewer night-time low blood sugar events over 6-month
study period, vs. Lantus(R)-
Sanofi (EURONEXT : SAN and NYSE : SNY) announced today full results from
EDITION JP I and EDITION JP II that showed Toujeo(R) (insulin glargine [rDNA
origin] injection, 300 U/mL) achieved similar blood sugar control with fewer
people with type 1 and type 2 diabetes experiencing night-time low blood sugar
events compared with Lantus(R) (insulin glargine [rDNA origin] injection, 100
U/mL).
In Japanese people with uncontrolled type 1 diabetes (EDITION JP I),
incidence of low blood sugar events at night was 15% lower with Toujeo as
compared to Lantus over the 6-month study period (68.9% vs. 81.0%,
respectively; relative risk [RR] 0.85). Risk reduction of night-time low blood
sugar events compared with Lantus was particularly pronounced during the
titration period; 29% fewer patients experienced night-time low blood sugar
events during the first 8 weeks of treatment with Toujeo vs. Lantus (43.4% vs.
61.2%, respectively; RR 0.71).
In Japanese people with type 2 diabetes uncontrolled on basal insulin and
oral anti-diabetics (EDITION JP II), incidence of low blood sugar events at
night-time was also reduced (38% fewer patients experiencing greater than or
equal to1 event over 6-month study period; 28.3% with U300 vs. 45.8%, with
Lantus; RR 0.62).
Event rates (per patient-year) of low blood sugar at night-time and at any
time of the day (over 24 hours) were also consistently lower with Toujeo
compared with Lantus across both studies over the 6-month study period.
"The reduction in low blood sugar events during the titration phase, which
has been noted in multiple type 1 and type 2 diabetes patient types across the
EDITION program, has now been demonstrated in this Japanese population,"
commented Yasuo Terauchi, Principal Investigator of the EDITION JP II study and
Professor at Yokohama City University School of Medicine, Kanagawa. "As insulin
initiation represents a very critical phase of the patients' treatment pathway,
reduction in hypoglycemia during the first 8 weeks of insulin therapy could
potentially assist patients in starting and staying on insulin therapy."
"With over 9 million people living with diabetes in Japan, results from
EDITION JP I and II further add to the growing positive Phase 3 data for
Toujeo," said Pierre Chancel, Senior Vice President, Global Diabetes Division,
Sanofi.
Results from EDITION JP I and II were presented at the 74th Scientific
Sessions of the American Diabetes Association.
EDITION JP I Full Results[1]
In Japanese people with type 1 diabetes, EDITION JP I (n=243) met its
primary endpoint by showing similar blood sugar level control (reduction in
HbA1C) from baseline between Toujeo and Lantus at 6 months [LS mean change (SE)
-0.30 (0.06) and -0.43 (0.06) respectively; difference 0.13% (95% CI: -0.03 to
0.29)].
The percentage of participants with greater than or equal to1 severe or
confirmed (defined by plasma glucose less than or equal to70 mg/dL) night-time
low blood sugar event over the 6-month study period was lower with U300 vs.
Lantus [68.9% vs. 81.0%, respectively; RR 0.85 (95% CI: 0.73 to 0.99)]. This
effect was particularly apparent during the titration phase, with 29% fewer
patients experiencing night-time low blood sugar with Toujeo compared with
Lantus [43.4% vs. 61.2%, respectively; RR 0.71 (95% CI: 0.56 to 0.91)].
Furthermore, annualized rates of low blood sugar events at night-time were
consistently lower over the 6-month study period (7.46 vs. 11.24
events/participant-year; RR 0.66 [95% CI 0.48 to 0.92]). There were similar
findings between groups for adverse events, including hypersensitivity
reactions (6.6% vs. 11.6%, respectively). No injection site reactions were
reported in any patient in either treatment group.
EDITION JP II Full Results[2]
In Japanese people with type 2 diabetes who failed to control their blood
sugar levels on previous basal insulin and oral medication, EDITION JP II
(n=241) met its primary endpoint by showing similar blood sugar level control
(reduction in HbA1C) from baseline between Toujeo and Lantus at 6 months [LS
mean change (SE) -0.45 (0.06) and -0.55 (0.06) respectively; difference 0.10%
(95% CI: -0.08 to 0.27).
The percentage of participants with greater than or equal to1 severe or
confirmed (defined by plasma glucose less than or equal to70 mg/dL) low blood
sugar event at night-time over the 6-month treatment period was lower with
Toujeo vs. Lantus [28.3% vs. 45.8%, respectively; RR 0.62 (95% CI: 0.44 to
0.88)]. A 55% risk reduction in the annualized rate of low blood sugar events
at night-time was observed at month 6 (2.18 vs. 4.98 events/participant-year;
RR 0.45 [95% CI 0.21 to 0.96]).
In addition, the patients treated with Toujeo lost weight, compared with a
slight increase in the Lantus group (-0.6 kg vs. 0.4 kg, respectively). There
were similar findings between groups for adverse events, including
hypersensitivity reactions (9.2% vs, 8.3%, respectively) and injection site
reactions (1.7% vs. 0.8%, respectively).
About Toujeo(R)
Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL; formerly
called "U300") is an investigational new basal insulin currently in development
for the treatment of people with diabetes mellitus. Toujeo is the intended
trade name for U300. Toujeo is not currently approved or licensed anywhere in
the world.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi has core strengths in
the field of healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets, animal
health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
References
1) New Insulin Glargine 300 U/mL: Glycemic Control and Hypogylcemia in
Japanese People with T1DM (EDITION JP 1). Matsuhisa M et al. Poster
presentation, June 15, 2014 12:00 - 14:00 (ABS 88-LB).
2) Glycemic Control and Hypoglycemia in Japanese People with T2DM Receiving
New Insulin Glargine 300 U/mL in Combination with OADs (EDITION JP 2). Terauchi
Y et al. Poster presentation, June 15, 2014 12:00 - 14:00 (ABS 94-LB).
Forward Looking Statements
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SOURCE: Sanofi Diabetes
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