Toujeo(R) Demonstrates a More Stable Profile and Lower Within-day Variability Compared to Insulin Degludec

PR65766

PARIS, Sep. 15, 2016 /PRNewswire=KYODO JBN/ --

     Further comparative data expected from ongoing head-to-head clinical trial

    Sanofi [http://www.sanofi.com ] announced today the key results of a new

pharmacokinetic / pharmacodynamic (PK/PD) study in people with type 1 diabetes

comparing Toujeo(R) (insulin glargine 300 Units/mL) to insulin degludec U100.

    The study demonstrated a more stable PK/PD profile over the dosing interval

of 24 hours at steady state, in favor of Toujeo(R). When dosed at 0.4

Units/kg/day, patients showed a more even distribution of insulin exposure and

activity with Toujeo(R) compared to insulin degludec.

    With Toujeo(R), 67% of the study participants also achieved lower

within-day variability of metabolic activity than with insulin degludec,

measured by changes in the glucose infusion rate. Both insulins were measurable

until the end of the observation period, at 30 hours.[1]

    "PK/PD studies are critical tools to characterize the pharmacological

differences between insulins. In this study we observed a more favorable

profile for Toujeo(R) compared to insulin degludec," said Riccardo Perfetti,

Head of Global Diabetes Medical Team, Sanofi. "The clinical implications of

those findings are currently being investigated by a large randomized study."[2]

    In a poster presentation this week at the European Association for the

Study of Diabetes (EASD) 52nd Annual Meeting, meta-analyses gave a clinical

perspective on the EDITION and BEGIN clinical trial programs with Toujeo(R) and

insulin degludec, respectively.[3]

    About the PK/PD study (LPS14585)

    This was a randomized, single-center, double-blind, 2-treatment, 2-period,

2-sequence cross-over, 8-day multiple dosing study with a steady state

euglycemic glucose clamp, in 48 T1DM patients. The study compared the

pharmacodynamic and pharmacokinetic properties of 0.4 and 0.6 Units/kg/day of

Toujeo with the same dose levels of insulin degludec. The main PD parameter in

this study was the within-day fluctuation of the smoothed glucose infusion rate

time curve within 24 hours (GIR0-24) in steady state (GIR-smFL0-24), which was

defined as the area between the individual smoothed GIR time curve and the

individual average GIR line from study drug administration on Day 8 until 24

hours after ("within-day variability").[1]

    About Toujeo(R)

    Toujeo(R) 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(R) 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 )

[http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx ] and in New

York (NYSE: SNY )

[http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx ])

    References

    1) Sanofi, data on file (2016).

    2) Sanofi, ClinicalTrials.Gov,

https://clinicaltrials.gov/ct2/show/NCT02738151 [Accessed September 2016].

    3) Roussel R, et al. Poster presentation #914, European Association for the

Study of Diabetes (EASD) 52nd Annual Meeting, September 12-16, Munich, Germany.

    SOURCE: Sanofi