PARIS, June 6, 2015 /PRNewswire/ --
Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia® (lixisenatide) met all co-primary endpoints in a clinical trial (GetGoal Duo-2) comparing its use as a once-daily add-on to basal insulin versus the addition of rapid acting insulin injected once each day at main meal (basal-plus) or three times daily at each meal (basal-bolus). Participants were adults with type 2 diabetes poorly controlled on basal insulin. Lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c) and statistically superior to basal-bolus for body weight change, as co-primary endpoints for the study.
"There is a need for expanding the options, beyond injectable rapid acting insulin, to facilitate advancing and further improving basal insulin replacement therapy," commented lead investigator Julio Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center at Medical City. "This study shows that the addition oflixisenatide to basal insulin was meaningfully effective with some additional benefits over rapid acting insulin."
The study also showed that documented hypoglycemia was numerically lower in the lixisenatide group versus the group receiving rapid acting insulin once each day and significantly lower versus the group receiving rapid acting insulin three times each day.
"This study demonstrates that hypoglycemia and weight gain could be minimized while normalizing glycemia in patients using lixisenatide. Sanofi continues to develop our portfolio of treatments with an overarching goal of meeting the individual needs of as many people as possible living with diabetes," added Riccardo Perfetti, M.D., Vice President Medical Affairs, Global Diabetes at Sanofi.
The results will be shared with health authorities worldwide and will be included in the New Drug Application forlixisenatide, which is on track to be resubmitted to the U.S. Food and Drug Administration in the third-quarter of 2015, and they were presented at the 75th Scientific Sessions of the American Diabetes Association, Boston, MA, U.S. The abstract is titled: Advancing Basal Insulin Glargine with Prandial Lixisenatide QD vs InsulinGlulisine QD or TID in T2DM: The GetGoal Duo-2 Evidence-Based Trial (NCT01768559). (Rosenstock et al. Poster presentation 107-LB, June 7, 2015).
Results of Analysis
The 26-week, randomized, open-label study compared the addition of once-daily lixisenatide (20 µg) to optimally titrated insulin glargine with/without metformin versus the addition of one daily injection (basal-plus) or three daily injections (basal-bolus) of insulin glulisine with or without metformin. Participants were predominantly obese and had been poorly controlled on basal insulin ± oral anti-diabetics (OADs) for at least 6 months prior to the study.
Lixisenatide was shown to be non-inferior to both comparator regimens for reduction in blood sugar (HbA1c) (LS mean difference [95% CI]: -0.05% [-0.17 to 0.06] vs. basal-plus; 0.21% [0.10 to 0.33] vs. basal-bolus; mITTn=890), and superior to basal-bolus for body weight change (LS mean difference [95% CI]: -2.0kg [-2.6 to -1.4kg], p<0.0001 vs. basal-bolus). In addition, post-prandial glucose (PPG) was measured in patients treated before breakfast, and was significantly reduced with lixisenatide compared with both insulin glulisine regimens (LS mean difference [95% CI]: -37mg/dL [-59 to -15mg/dL] vs. basal-plus; -40md/dL [-61 to -19mg/dL] vs. basal-bolus).
Documented hypoglycemia was numerically and statistically lower with lixisenatide than with
basal-plus and basal-bolus, respectively (estimated rate ratio [95% CI]: 0.8 [0.5 to 1.1], p=0.123 vs. basal-plus; 0.5 [0.3 to 0.7], p<0.0001 vs. basal-bolus; safety n=893). Nausea events were higher with lixisenatide (25% of patients receiving lixisenatide experienced one or more nausea event, 2% of patients on basal-plus regimen, and 1% of patients on basal-bolus). Patients receiving lixisenatide also reported vomiting (9%) and diarrhea(7%).
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), http://www.zealandpharma.com , and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemiccontrol in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is currently approved in over 50 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide. Lixisenatide is an investigational product in the U.S. It will be resubmitted to the Food & Drug Administration (FDA) in the third quarter of 2015. The proprietary name in the U.S. is under consideration.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.
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 Genzyme. 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 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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.