Further comparative data expected from ongoing
head-to-head clinical trial
PARIS, Sept. 15, 2016 /CNW/ - Sanofi announced today the
key results of a new pharmacokinetic / pharmacodynamic (PK/PD)
study in people with type 1 diabetes comparing Toujeo®
(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®. When dosed at 0.4 Units/kg/day, patients showed
a more even distribution of insulin exposure and activity with
Toujeo® compared to insulin degludec.
With Toujeo®, 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®
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® 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®
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).
References
- Sanofi, data on file (2016).
- Sanofi, ClinicalTrials.Gov,
https://clinicaltrials.gov/ct2/show/NCT02738151 [Accessed
September 2016].
- 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