Sanofi announced full results from EDITION II (basal insulin + oral therapy) and additional results from its EDITION Phase 3 program for EDITION III, EDITION IV, and EDITION JP I for the investigational new insulin U300 in patients with type 1 or type 2 diabetes. Insulin U300 is a new formulation based on the glargine molecule, the biological entity of Lantus (insulin glargine [rDNA origin] injection). Lantus is a long-acting insulin already approved for the treatment of adults with type 2 diabetes and patients ≥6 years of age with type 1 diabetes for the control of high blood sugar.
EDITION II included type 2 diabetes patients, who failed to control their blood sugar levels on previous basal insulin and oral medication, together with a long duration of disease and high body mass index (BMI). The study randomized 811 participants 1:1 to U300 (n=404) or Lantus (n=407) once daily in the evening, while continuing oral anti-diabetics. EDITION II met its primary endpoint by showing similar reductions in HbA1c from baseline between U300 and Lantus at 6 months [least squares mean change -0.57% (0.09) and -0.56% (0.09), respectively; difference -0.01% (95% CI: -0.14 to +0.12)] with 23% fewer patients experiencing night-time low blood sugar compared with Lantus.
EDITION III compared U300 with Lantus in 878 people with type 2 diabetes not previously treated with insulin and uncontrolled on oral medication. The primary endpoint of similar blood sugar level control as measured by HbA1c from baseline to month 6 was met (-1.42% [95% CI: -1.511 to -1.326] in the U300 group, and -1.46% [95% CI: -1.555 to -1.367] in the Lantus group).
EDITION IV and JP1 studies compared U300 with Lantus in people with type 1 diabetes treated with basal and mealtime insulin. EDITION IV enrolled 549 patients internationally, while EDITION JP I was conducted in 243 Japanese patients. The primary endpoint was met in both studies which showed similar reductions in HbA1c from baseline between U300 and Lantus at 6 months. (EDITION IV: -0.40% [95% CI: -0.501 to -0.299] in the U300 group, and -0.44% [95% CI: -0.543 to -0.344] in the Lantus group); EDITION JP I: -0.30% [95% CI: -0.411 to -0.183] in the U300 group, and -0.43% [95% CI: -0.542 to -0.313] in the Lantus group).
Full results for EDITION III, EDITION IV, EDITION JP I, and EDITION JP II (Japanese type 2 diabetes patients treated with basal insulin + oral therapy) will be presented in 2014.
Sanofi anticipates the regulatory submissions to FDA in the first half of 2014.
For more information call (800) 446-6267 or visit Sanofi-Aventis.us.