Sanofi Announces Positive Phase 3 Results for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL) in Japanese People with Uncontrolled Diabetes

Paris (ots/PRNewswire) -

- 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 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 and in New York .

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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ots Originaltext: Sanofi Diabetes
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts: Media Relations: Jack Cox, Tel.: +(33)1-53-77-46-46,
jack.cox@sanofi.com. Investor Relations: Sébastien Martel, Tel.:
+(33)1-53-77-45-45, ir@sanofi.com. Global Diabetes Communications:
Tilmann
Kiessling, Mobile: +49-17-26-15-92-91, Tilmann.kiessling@sanofi.com