Sanofi Announces Positive Phase 3 Results for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL) in Japanese People with Uncontrolled Diabetes

PARIS, June 14, 2014 /PRNewswire/ --

- In EDITION JP I and II, investigational Toujeo^® demonstrated similar blood sugar control with fewer night-time low blood sugar events over 6-month study period, vs. Lantus^® - 

Sanofi (EURONEXT : SAN and NYSE : SNY) announced today full results from EDITION JP I and EDITION JP II that showed Toujeo^® (insulin glargine [rDNA origin] injection, 300 U/mL) achieved similar blood sugar control with fewer people with type 1 and type 2 diabetes experiencing night-time low blood sugar events compared with Lantus^® (insulin glargine [rDNA origin] injection, 100 U/mL).

In Japanese people with uncontrolled type 1 diabetes (EDITION JP I), incidence of low blood sugar events at night was 15% lower with Toujeo as compared to Lantus over the 6-month study period (68.9% vs. 81.0%, respectively; relative risk [RR] 0.85). Risk reduction of night-time low blood sugar events compared with Lantus was particularly pronounced during the titration period; 29% fewer patients experienced night-time low blood sugar events during the first 8 weeks of treatment with Toujeo vs. Lantus (43.4% vs. 61.2%, respectively; RR 0.71).

In Japanese people with type 2 diabetes uncontrolled on basal insulin and oral anti-diabetics (EDITION JP II), incidence of low blood sugar events at night-time was also reduced (38% fewer patients experiencing ≥1 event over 6-month study period; 28.3% with U300 vs. 45.8%, with Lantus; RR 0.62).

Event rates (per patient-year) of low blood sugar at night-time and at any time of the day (over 24 hours) were also consistently lower with Toujeo compared with Lantus across both studies over the 6-month study period.

"The reduction in low blood sugar events during the titration phase, which has been noted in multiple type 1 and type 2 diabetes patient types across the EDITION program, has now been demonstrated in this Japanese population," commented Yasuo Terauchi, Principal Investigator of the EDITION JP II study and Professor at Yokohama City University School of Medicine, Kanagawa. "As insulin initiation represents a very critical phase of the patients' treatment pathway, reduction in hypoglycemia during the first 8 weeks of insulin therapy could potentially assist patients in starting and staying on insulin therapy."

"With over 9 million people living with diabetes in Japan, results from EDITION JP I and II further add to the growing positive Phase 3 data for Toujeo," said Pierre Chancel, Senior Vice President, Global Diabetes Division, Sanofi.

Results from EDITION JP I and II were presented at the 74^th Scientific Sessions of the American Diabetes Association.

EDITION JP I Full Results^[1]

In Japanese people with type 1 diabetes, EDITION JP I (n=243) met its primary endpoint by showing similar blood sugar level control (reduction in HbA_1C) from baseline between Toujeo and Lantus at 6 months [LS mean change (SE) -0.30 (0.06) and -0.43 (0.06) respectively; difference 0.13% (95% CI: -0.03 to 0.29)].

The percentage of participants with ≥1 severe or confirmed (defined by plasma glucose ≤70 mg/dL) night-time low blood sugar event over the 6-month study period was lower with U300 vs. Lantus [68.9% vs. 81.0%, respectively; RR 0.85 (95% CI: 0.73 to 0.99)]. This effect was particularly apparent during the titration phase, with 29% fewer patients experiencing night-time low blood sugar with Toujeo compared with Lantus [43.4% vs. 61.2%, respectively; RR 0.71 (95% CI: 0.56 to 0.91)]. Furthermore, annualized rates of low blood sugar events at night-time were consistently lower over the 6-month study period (7.46 vs. 11.24 events/participant-year; RR 0.66 [95% CI 0.48 to 0.92]). There were similar findings between groups for adverse events, including hypersensitivity reactions (6.6% vs. 11.6%, respectively). No injection site reactions were reported in any patient in either treatment group.

EDITION JP II Full Results^[2]

In Japanese people with type 2 diabetes who failed to control their blood sugar levels on previous basal insulin and oral medication, EDITION JP II (n=241) met its primary endpoint by showing similar blood sugar level control (reduction in HbA_1C) from baseline between Toujeo and Lantus at 6 months [LS mean change (SE) -0.45 (0.06) and -0.55 (0.06) respectively; difference 0.10% (95% CI: -0.08 to 0.27).

The percentage of participants with ≥1 severe or confirmed (defined by plasma glucose ≤70 mg/dL) low blood sugar event at night-time over the 6-month treatment period was lower with Toujeo vs. Lantus [28.3% vs. 45.8%, respectively; RR 0.62 (95% CI: 0.44 to 0.88)]. A 55% risk reduction in the annualized rate of low blood sugar events at night-time was observed at month 6 (2.18 vs. 4.98 events/participant-year; RR 0.45 [95% CI 0.21 to 0.96]).

In addition, the patients treated with Toujeo lost weight, compared with a slight increase in the Lantus group (-0.6 kg vs. 0.4 kg, respectively). There were similar findings between groups for adverse events, including hypersensitivity reactions (9.2% vs, 8.3%, respectively) and injection site reactions (1.7% vs. 0.8%, respectively).

About Toujeo^® 

Toujeo^® (insulin glargine [rDNA origin] injection, 300 U/mL; formerly called "U300") is an investigational new basal insulin currently in development for the treatment of people with diabetes mellitus. Toujeo is the intended trade name for U300. Toujeo is not currently approved or licensed anywhere in the world.

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).

References 

1. New Insulin Glargine 300 U/mL: Glycemic Control and Hypogylcemia in Japanese People with T1DM (EDITION JP 1). Matsuhisa M et al. Poster presentation, June 15, 2014 12:00 − 14:00 (ABS 88-LB).
2. Glycemic Control and Hypoglycemia in Japanese People with T2DM Receiving New Insulin Glargine 300 U/mL in Combination with OADs (EDITION JP 2). Terauchi Y et al. Poster presentation, June 15, 2014 12:00 − 14:00 (ABS 94-LB).

Forward Looking Statements 

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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.