Meta-Analysis Shows More Sustained Reduction in Blood Sugar with Toujeo® vs. Lantus® at One Year

– Also shows lower risk of hypoglycemia and more favorable weight profile –

– Results further support and extend clinical benefits of Toujeo®

Paris, France – September 15, 2015 – Sanofi announced today that a comprehensive meta-analysis including one-year data from the EDITION 1, 2 and 3 studies in people with type 2 diabetes showed a more sustained reduction in blood sugar for Toujeo® (insulin glargine [rDNA origin] injection, 300 Units/mL) compared with Lantus® (insulin glargine [rDNA origin] injection, 100 Units/mL). Toujeo® also demonstrated a reduced risk of hypoglycemia at any time of day and at night, in addition to a beneficial effect on weight gain. This analysis extends the meta-analysis of 6-month results published recently.1

These results further highlight the clinical benefits Toujeo® can offer to people with diabetes worldwide,” said Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical Affairs, Diabetes Division, Sanofi. “They build on the existing EDITION findings for blood sugar control, demonstrating that Toujeo® can provide a sustained blood sugar reduction over time, while lowering the risk of hypoglycemia, compared with Lantus®. We continue to be encouraged by positive analyses from EDITION, as Toujeo® continues to launch around the world.”

Professor Robert Ritzel from Munich, Germany, Lead Author for the meta-analysis, also commented: “Sustained blood sugar control is important for treatment adherence and positive outcomes in type 2 diabetes. This meta-analysis confirms that Toujeo® allows sustained daily blood glucose control and clinically adequate up-titration of the insulin dose without increased risk of hypoglycemia, and demonstrates that these benefits translate into long-term outcomes, such as a lower risk of any-time and night-time hypoglycemia or less weight gain, alongside a greater HbA1c reduction after 1 year of treatment compared with Lantus®.

EDITION 1/2/3 One-Year Meta-Analysis
EDITION 1, 2 and 3 assessed Toujeo® versus Lantus® in a diverse population of people with type 2 diabetes. A patient-level meta-analysis of one-year data was conducted. Blood sugar control was sustained in both groups, with more sustained HbA1c reduction for Toujeo® at one year (LS mean difference [95% confidence interval (CI)] between groups in HbA1c change from baseline −0.10 [−0.18 to −0.02] %; p=0.0174). There was a reduced risk of confirmed (≤70 mg/dL) or severe hypoglycemia at any time (24 hr) (percentage of people ≥1 event, relative risk [95% CI] 0.94 [0.90 to 0.98]) and during the night (00:00–05:59 hr) (RR 0.85 [0.77 to 0.92]) versus Lantus®. Weight gain was less with Toujeo® versus Lantus® (LS mean difference in change from baseline to 1 year: 0.40 kg; p=0.0117). The insulin dose difference at six months remained at one year.

The results are being presented at the European Association for the Study of Diabetes (EASD) 51st Annual Meeting in Stockholm, Sweden. The abstract is titled: Patient-level meta-analysis of 1y phase 3a EDITION type 2 diabetes mellitus studies: glycaemic control and hypoglycaemia with insulin glargine 300 U/ml (Gla-300) vs glargine 100 U/ml (Gla-100). (Ritzel et al. Poster presentation #975).

About Toujeo
Despite basal insulin being a cornerstone treatment for diabetes for decades, significant unmet medical needs remain a reality, with approximately half of patients on treatment not reaching their blood sugar level targets.2-7 In addition, optimal insulin dose is often not reached during initiation or maintenance phase. Toujeo is a next-generation, once-daily basal insulin based on a broadly-used molecule (insulin glargine) with a well-established benefit-risk profile.8 Its compact subcutaneous depot leads to more stable and more prolonged pharmacokinetic/pharmacodynamic (PK/PD) profiles.9-11 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.

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.

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 Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

References
1.    Ritzel R, et al. Diabetes Obes Metab. 2015;17(9):859-67, DOI: 10.1111/dom.12485.
2.    Banegas JR, et al. Eur Heart J. 2011;32(17):2143-52, DOI: 10.1093/eurheartj/ehr080.
3.    Chan JCN, et al. Diabetes Care. 2009;32(2):227-33, DOI: 10.2337/dc08-0435.
4.    Choi YJ, et al. Diabetes Care. 2009;32(11):2016-20, DOI: 10.2337/dc08-2228.
5.    Stark Casagrande S, et al. Diabetes Care. 2013;36(8):2271-9, DOI: 10.2337/dc12-2258.
6.    Steinberg BA, et al. American Heart Journal. 2008;156(4):719-27, DOI: 10.1016/j.ahj.2008.05.020.
7.    Vouri SM, et al. J Manag Care Pharm. 2011;17(4):304-12, http://www.ncbi.nlm.nih.gov/pubmed/21534641.
8.    Gerstein HC, et al. N Engl J Med. 2012;367(4):319-28, DOI: 10.1056/NEJMoa1203858.
9.    Shiramoto M, et al. Diabetes Obes Metab. 2015;17(3):254-60, DOI: 10.1111/dom.12415.
10.   Becker RHA, et al. Diabetes Care. 2015;38(4):637-43, DOI: 10.2337/dc14-0006.
​11.   Steinstraesser A, et al. Diabetes Obes Metab. 2014;16(9):873-6, DOI: 10.1111/dom.12283.

Contact:

Global Diabetes Communications
Philip McNamara
Tel.: +1 908 981 5497
philip.mcnamara@sanofi.com