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Sanofi Presents New Data for an Investigational Fixed-Ratio Combination of Insulin Glargine and Lixisenatide at the European Association for the Study of Diabetes 52nd Annual Meeting

New results from the pivotal phase III LixiLan-L trial showed the fixed-ratio combination helps more patients reach mealtime blood sugar target than insulin glargine alone

 

Guildford, United Kingdom – 14 September, 2016 - Sanofi announced today new data supporting a fixed-ratio combination of insulin glargine and lixisenatide to be presented at the European Association for the Study of Diabetes 52nd Annual Meeting in Munich, Germany.

There are currently 3.5 million people in the UK diagnosed with diabetes1 a figure predicted to rise to an estimated five million people by 2025.1Over two thirds of adults treated with insulin do not reach the National Institute for Health and Care Excellence (NICE) target for blood glucose control (HbA1c ≤ 7.5%), increasing their risk of potentially avoidable complications such as amputation, blindness and renal disease.1

Dr Mike Baxter, medical therapy expert at Sanofi UK said, “Blood glucose management in the UK is amongst the worst in Europe with, on average, people with type 2 diabetes having the highest blood glucose levels compared to nine other developed countries. This latest study reflects Sanofi’s ongoing commitment to innovative approaches in developing medicines that are intended to help patients manage their condition and reduce the risk of avoidable complications”.

New results from the LixiLan-L study, a trial investigating a titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide (iGlarLixi) in adults with type 2 diabetes, showed in patients with type 2 diabetes (T2D) uncontrolled with basal insulin, the fixed-ratio combination demonstrated greater post meal glycaemic control compared with insulin glargine alone, with consistently more patients reaching postprandial plasma glucose (PPG) targets after all meals throughout the day.3

The study will be presented at the European Association for the Study of Diabetes 52nd Annual Meetings:

  • Postprandial glycaemic outcomes of a fixed-ratio combination of insulin glargine and lixisenatide in the LixiLan-L trial (Vidal, J et al. Poster presentation 801, European Association for the Study of Diabetes 52nd Annual Meeting, Munich, Germany at Tues. 13 Sept, 13:15 - 14:15)

The fixed dose combination of insulin glargine and lixisenatide is currently undergoing licensing review by the European Medicines Agency (EMA).

Results of Analyses

LixiLan-L
LixiLan-L investigated the efficacy and safety of the titratable fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide (iGlarLixi) versus treatment with insulin glargine 100 Units/mL (iGlar) over a 30-week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study while other oral agents were discontinued.

Post hoc analyses were performed to assess the percentage of patients reaching PPG <7.8 (AACE target) or <10 mmol/L (ADA/EASD target) at 0.5, 1 and 2 h after a standardised liquid meal at baseline and Week 30, PPG 02 h area under the curve (AUC02h; after breakfast liquid meal) change at Week 30 (end of treatment), and 7point self-monitored plasma glucose (SMPG) at selected times. P-values were calculated between treatment groups for all parameters analysed. At Week 30, the percentage of patients with PPG <7.8 mmol/L and <10 mmol/L at 0.5, 1 and 2 h post standardised liquid meal was greater in the iGlarLixi group versus the iGlar group; this difference was greatest at later time points postmeal. Compared with iGlar, treatment with iGlarLixi also resulted in a significantly greater reduction in PPG AUC02h. SMPG profiles at time points after three daily meals showed larger percentages of iGlarLixi patients at the PPG targets compared with iGlar, with the difference decreasing postdinner.3

In patients with T2D uncontrolled with basal insulin in LixiLanL, iGlarLixi demonstrated greater postprandial glycaemic control compared with iGlar, with consistently more patients reaching PPG targets after all meals throughout the day.3

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organised 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 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 initiatives 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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contact:

Media Relations
Alexandre Morvan
Tel. +44 (0) 7710 388101
alexandre.morvan@sanofi.com

References

1   Diabetes UK Facts and Stats. 2015. Available at:
https://www.diabetes.org.uk/Documents/Position%20statements/Diabetes%20UK%20Facts%20and%20Stats_Dec%202015.pdf. Last accessed June 2016.

2 Sanofi Data on File. SAGB.DIA.14.10.0602

3  Vidal, J et al. 'Postprandial glycaemic outcomes of a fixed-ratio combination of insulin glargine and lixisenatide in the LixiLan-L trial' Poster presentation 801, European Association for the Study of Diabetes 52nd Annual Meeting' Available at: http://www.easdvirtualmeeting.org/resources/postprandial-glycaemic-outcomes-of-a-fixed-ratio-combination-of-insulin-glargine-and-lixisenatide-in-the-lixilan-l-trial

 

Date of preparation: September 2016 - Job bag number: SAGB.DIA.16.09.0857

Updated: September 14, 2016

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