- Meta-analysis of three late-stage trials in people with type 2 diabetes shows decreases in risk of low blood sugar events of up to 31% at night-time compared with Lantus®
- All studies in the phase 3 “EDITION” clinical trial program, including a study with type 1 patients, met their primary endpoint
- Toujeo dossier accepted by the EMA
Paris, France, 16-6-2014 — /EuropaWire/ — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that, in a pooled analysis, investigational therapy Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL) consistently showed significantly fewer low blood sugar events (hypoglycemia) at any time of day, including night-time events, compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL). The pooled analysis comprised data from three differing type 2 patient populations. In this analysis, more pronounced, significant reductions in low blood sugar rates at any time of day, including nighttime, were observed with Toujeo during the 8-week titration period when compared with Lantus.
“Toujeo has been recently accepted for review by EMA and this important milestone is another step forward in expanding our insulin portfolio,” said Pierre Chancel, Senior VP, Global Diabetes Division, Sanofi. “We continue to be encouraged by the positive Phase 3 results from EDITION, which demonstrated the potential of Toujeo to help meet unmet needs of people living with diabetes.”
Type 2 Diabetes
The pooled analysis was comprised of studies I, II and III from the EDITION program, a worldwide and extensive series of Phase 3 studies evaluating the efficacy and safety of Toujeo in broader and diverse populations of people with type 2 diabetes. Full EDITION I and II results have been previously reported.
Full results from the EDITION III trial showed that significantly fewer people with type 2 diabetes, new to insulin therapy, experienced low blood sugar events during the night over the study period (post-hoc analysis) when treated with Toujeo compared with Lantus. This effect was numerically more pronounced, although not significant, during the first 8-week titration phase.
All of studies from the phase 3 EDITION clinical program presented at the 74th Scientific Sessions of the American Diabetes Association, like previously reported studies, met their primary endpoint by demonstrating similar blood sugar control with Toujeo as compared with Lantus.
Geremia Bolli, Principal Investigator of the EDITION III study and Professor of Endocrinology, University of Perugia, Italy, commented: “Low blood sugar events, at any time of the day or night, should not be underestimated – particularly for those who are starting out with a new or alternate insulin therapy. As it is well known in clinical practice, many people go through a sensitive phase when starting insulin, and they tend to drop the treatment or not properly up-titrate when exposed to low blood sugar events. Reducing low blood sugar events in this particular phase is relevant in helping patients better manage diabetes.’’
EDITION I/II/III Meta-Analysis
In a diverse population of people with type 2 diabetes (n=2476), a post-hoc pooled analysis of EDITION I, II and III demonstrated the rate ratio (per participant-year) of night-time low blood sugar events was reduced by 31% (significant) for Toujeo compared with Lantus over the 6-month study period (rate ratio: 0.69 [95% CI: 0.57 to 0.84]; p=0.0002). In addition, the rate ratio was reduced (per participant-year) by 14% (significant) for low blood sugar events at any time of the day for Toujeo vs. Lantus (RR: 0.86 [95% CI: 0.77 to 0.97]; p=0.0116).
The EDITION I/II/III meta-analysis abstract is titled: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in a Meta-analysis of Phase 3a EDITION Clinical Trials in People with T2DM. (Ritzel et al. Poster presentation, June 15, 2014 12:00 − 14:00 pm PDT [ABS 90-LB]).
EDITION III Full Results
In people with type 2 diabetes who failed to control their blood sugar levels by treatments other than insulin, EDITION III (n=878) 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 -1.42 (0.05) and -1.46 (0.05) respectively; difference 0.04% (95% CI: -0.09 to 0.17)].
The percentage of participants with severe or confirmed (defined by plasma glucose ≤70 mg/dL) night-time low blood sugar events (nocturnal hypoglycemia) from week 9 to month 6 (pre-specified main secondary endpoint) was similar. Over the 6-month treatment period, the incidence of any night-time low blood sugar events (% of participants with ≥1 event) was lower with Toujeo vs. Lantus [RR: 0.76 (95% CI: 0.59 to 0.99)], particularly in the insulin titration phase, with 26% risk reduction in patients experiencing night-time low blood sugar events with Toujeo vs. Lantus [RR: 0.74 (95% CI: 0.48 to 1.13)] during the first 8 weeks of treatment.
In addition, there was a 25% risk reduction (event/ participant-year) of low blood sugar events at any time of day or night across the entire 6-month study period for Toujeo vs. Lantus [RR: 0.75 (95% CI: 0.57 to 0.99)].There were similar findings between groups for adverse events, including hypersensitivity reactions (6.9% vs. 5.7%, respectively) and injection site reactions (3.9% vs. 4.8%, respectively).
The EDITION III abstract is titled: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in Insulin Naïve People with T2DM (EDITION 3). (Bolli et al. Oral presentation, June 14, 2014 09:00 am PDT [ABS 68-OR]).
Toujeo Dosing Variation Study
Three-month sub-studies of EDITION I and II in type 2 diabetes patients showed varying the timing of Toujeo injections by ± 3 hours at least two times each week resulted in similar blood glucose reduction and similar percentage of patients experiencing low blood sugar events compared with a fixed daily injection schedule.
The Toujeo -treatment groups of the original studies were further randomized to either a fixed dosing time (the same time in the evening) or an adaptable dosing regimen, which allowed 24 ± 3 hours between each dose of Toujeo on at least 2 days each week. This sub-study showed that the HbA1C change (primary endpoint) was similar between regimens [EDITION I: difference 0.05% (95% CI: -0.19 to 0.30); EDITION II: difference 0.13% (95% CI: -0.15 to 0.42)]. Percentages of participants with ≥1 low blood sugar event at any time of the day, or night, were also similar (EDITION I: 66.0% vs. 57.1% and EDITION II: 41.9% vs. 36.4%, for fixed vs. adaptable dosing time, respectively).
The Toujeo dosing variation study abstract is titled: New Insulin Glargine 300 U/mL: Efficacy and Safety of Adaptable vs Fixed Dosing Intervals in People with T2DM. (Riddle MC et al. Poster presentation, June 14, 2014 11:30 am –13:30 pm PDT [ABS 919-P])
Type 1 Diabetes: EDITION IV Results
EDITION IV full results showed that people with type 1 diabetes, randomized to Toujeo, experienced similar night-time and any-time of the day low blood sugar event rates with Toujeo compared with Lantus. In the insulin initiation phase, which was the first 8 weeks of the study, night-time low blood sugar event rates were significantly lower with Toujeo, compared with Lantus. Furthermore, EDITION IV results demonstrated similar glucose lowering and adverse event results for Toujeo regardless of whether it was injected in the morning or in the evening in type 1 patients. Variability in dosing was also investigated in two new subgroup studies in EDITION I and EDITION II. These studies demonstrated that glucose lowering and adverse events were similar for Toujeo vs Lantus when patients were able to vary their dosing schedule by up to ±3 hours.
In people with type 1 diabetes, EDITION IV (n=549) met its primary endpoint by showing Toujeo was non-inferior to Lantus for blood sugar control at 6 months [LS mean change in HbA1C -0.40 (0.05) and -0.44 (0.05) respectively; difference 0.04% (95% CI: -0.10 to 0.19)]. In this study, participants were randomized 1:1:1:1 to once-daily Toujeo or Lantus, morning or evening, while continuing meal-time insulin.
Event rates of confirmed or severe low blood sugar at any time of day or night across the entire 6-month study was similar for the two groups. The study indicated a 31% relative risk reduction (significant; event/patient-year) in night-time low blood sugar events in the first 8 weeks for Toujeo vs. Lantus (7.8% vs. 11.2%, [RR: 0.69 (95% CI: 0.53 to 0.91)]. There were similar findings between
groups for adverse events. Neither glycemic control nor low blood sugar events differed between morning and evening injection groups.
The EDITION IV abstract is titled: Glycemic Control and Hypoglycemia with New Insulin Glargine 300U/mL in People with T1DM (EDITION 4). (P.D. Home et al. Poster presentation, June 15, 2014 12:00 − 14:00 pm PDT [ABS 80-LB]).
Toujeo® is the intended trade name for insulin glargine [rDNA origin] injection, 300 U/mL; formerly abbreviated as “U300”. U300 is not currently approved or licensed anywhere in the world.
On May 27, 2014, the European Medicines Agency (EMA) accepted Sanofi’s marketing authorization dossier for insulin glargine (rDNA origin) injection 300 U/mL, for EU countries.
Sanofi has submitted the New Drug Application (NDA) for insulin glargine [rDNA origin] injection, 300 U/mL to the U.S. Food and Drug Administration (FDA). The formal acceptance of the submission is pending.
Conference Call on Diabetes for the financial community
Sanofi will host a Thematic Conference Call on Diabetes for the financial community in connection with the upcoming American Diabetes Association’s Scientific Sessions.
The call/webcast will take place on Monday, June 16, 2014 at:
6 pm Paris (CEST) │5 pm London (BST) │12 pm New York (EDT) │9 am San Francisco (PDT)
The conference call will include a presentation followed by a Q&A session. It will be accessible through audio webcast at www.sanofi.com and via the following telephone numbers:
CALL IN NUMBERS
France
+33 (0) 1 70 77 09 44
UK
+44 (0) 203 367 9453
USA
+1 866 907 59 28
AUDIO REPLAY
An audio replay of the call will be available through the numbers below. The replay will be available approximately 2 hours after the end of the call
REPLAY NUMBERS
France
+33 (0) 1 72 00 15 00
UK
+44 (0) 203 367 9460
USA
+1 877 64 230 18
REPLAY ACCESS CODE 287626#
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).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Contacts:
Media Relations
Jack Cox
Tel.: + (33) 1 53 77 45 02
jack.cox@sanofi.com
Investor Relations
Sébastien Martel
Tel.: + (33) 1 53 77 45 45
ir@sanofi.com
Global Diabetes Communications
Tilmann Kiessling
Mobile: +(49) 17 26 15 92 91
Tilmann.kiessling@sanofi.com
U.S. Diabetes Communications
Susan Brooks
Office: +1 (0) 908 981 6566
Mobile: +1 (0) 201 572 49 94
susan.brooks@sanofi.com
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- Digi Communications N.V. Announces that the offer of the Company’s Romanian subsidiary was designated winner of the auction organised for the allocation of certain radio frecquency entitlements
- New dating site aimed at people with mental health problems launches in Switzerland
- BITSCore Tests Satellite Cyber-Security and Ride-Share Algorithms on Australian Rocket
- StatusMatch.com ed Emirates collaborano per aiutare i frequenti viaggiatori italiani a tornare in volo
- StatusMatch.com and Emirates partner up to help Italian frequent flyers get back in the air
- MinDCet drivers and FTEX powertrain solutions enable EV GaN applications
- Digi Communications NV announces the release of the Q3 2021 Financial Results
- Origami and citoQualis Team up for Startups
- Digi Communications NV announces Investors Call for the Q3 Financial Results presentation
- Digi Communications N.V. announces the extraordinary general meeting’s resolution from 4 November 2021, approving the appointment of KPMG N.V. as the Company’s statutory auditor for the 2021 financial year
- Digi Communications N.V. announces The solution reached by the Bucharest Court of Appeal regarding the investigation conducted by the Romanian National Anticorruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V. Announces the results of the auction organised by the Portuguese Authority for Telecommunications
- Haizol expands its capabilities to include component assembly and product development
- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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