- 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® -
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
"With over 9 million people living with diabetes in
Results from EDITION JP I and II were presented at the 74th Scientific Sessions of the
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 =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
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 =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).
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.
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
New Insulin Glargine 300 U/mL: Glycemic Control and Hypogylcemia in
Japanese People with T1DM (EDITION JP 1). Matsuhisa M et al. Poster
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