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.
"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."
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.
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").
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.
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).
- 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.