Sanofi Announces Positive Phase 3 Results for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL) in Japanese People with Uncontrolled Diabetes
- In EDITION JP I and II, investigational Toujeo(R)demonstrated similar blood sugar control with fewer night-time low blood sugar events over 6-month study
period, vs. Lantus(R)-
Sanofi announced today full results from EDITION JP I and EDITION JP II that showed Toujeo(R) (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(R) (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 greater than or equal to1 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 74th Scientific Sessions of the American Diabetes Association.
EDITION JP I Full Results
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 HbA1C) 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 greater than or equal to1 severe or confirmed (defined by plasma glucose less than or equal to70 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
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 HbA1C) 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 greater than or equal to1 severe or confirmed (defined by plasma glucose less than or equal to70 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).
Toujeo(R) (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.
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 and in New York .
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
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