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