- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Sanofi announces positive results from Toujeo Phase III study extension
8 June 2015 • Author: Victoria White
Sanofi has announced results from the EDITION JP 1 and EDITION JP 2 extension studies where Japanese participants (with type 1 and type 2 diabetes, respectively) received Toujeo® or Lantus® treatment for a total of 12 months.
Over this entire study period, Toujeo maintained similar blood sugar control, with fewer people experiencing night-time low blood sugar events, compared with Lantus. These new results from EDITION JP 1 and 2 were presented at the 75th Scientific Sessions of the American Diabetes Association.
“The results of the EDITION JP 1 and 2 extension studies reaffirm the clinical benefit that Toujeo can bring to people who are living with uncontrolled diabetes”, said Pierre Chancel, Senior Vice President, Head of Global Diabetes, Sanofi. “As a new addition to our portfolio, Toujeo gives patients a further option to help them reach their glycaemic goals, and demonstrates our commitment to providing innovative therapies to enhance diabetes care.”
In Japanese people with uncontrolled type 1 diabetes (EDITION JP 1), confirmed night-time low blood sugar event rates and percentage of participants experiencing one or more events over the 12-month study period were comparable in both groups. However, hypoglycaemic event rate at the lower threshold (<54 mg/dL) was 38% lower with Toujeo. Risk reduction of night-time low blood sugar events at this threshold showed that 21% fewer patients experienced night-time low blood sugar events with Toujeo vs. Lantus.
EDITION JP 2 data demonstrates Toujeo’s ability to achieve sustainable glycaemic control
In Japanese people with type 2 diabetes uncontrolled on basal insulin and oral anti-diabetics (EDITION JP 2), incidence of low blood sugar events at night-time was also reduced (27% fewer patients experiencing one or more events over 12-month study period). Event rates of low blood sugar at night-time and any time of the day were consistently lower with Toujeo compared with Lantus. Over the 12-month period, people with type 2 diabetes treated with Toujeo and oral medications also saw a slight reduction in body weight, in comparison to those treated with Lantus who saw a slight increase.
“The additional data from the EDITION JP 2 study demonstrate Toujeo’s ability to achieve sustainable glycaemic control in the Japanese type 2 population,” commented Yasuo Terauchi, Principal Investigator of the EDITION JP 2 study and Professor at Yokohama City University School of Medicine, Kanagawa. “The reduction in episodes of hypoglycaemia observed and the additional weight findings demonstrated in EDITION JP 2 mean that Toujeo has the potential to help the people with type 2 diabetes in Japan to start and remain on insulin therapy in order to reach their long-term targets.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics