Sanofi, the maker of Lantus (insulin glargine), finished more phase III studies on their newest formulation of insulin glargine, U300, and discussed their results at the World Diabetes Congress 2013 in early December. The study results have not yet been published but researchers reported that the new formulation of insulin glargine has reduced incidences of daytime and nighttime hypoglycemia and also performed as well as Lantus with respect to controlling blood sugars.
Sanofi’s newest phase III studies have included EDITION III, EDITION IV and EDITION JP 1. EDITION III, which had approximately 800 participants, looked at a comparison of U300 to Lantus in patients with type 2 diabetes who were not currently on insulin therapy. The primary outcome measure was change in HbA1C from baseline to 6 months and secondary outcomes measured included hypoglycemia, fasting plasma glucose and 8 point self blood glucose monitoring. EDITION IV, which had approximately 500 participants looked at a comparison of U300 to Lantus in patients with type 1 diabetes and had the same primary and secondary outcome measures as in EDITION III but they added one additional secondary measure which was change in pre-injection plasma glucose and also assessed the change in fasting plasma glucose. And, EDITION JP 1 was the same as EDITION IV but was performed on the Japanese population and included approximately 240 participants. Each study was a 6-month, multicenter, randomized, open-label, parallel-group comparison study. Researchers say that results from each study were positive, meeting their goal/primary endpoints of similar changes in HBA1C from baseline as Lantus and also with U300 demonstrating less hypoglycemia during the day and night as compared to Lantus. As for their primary endpoint, change in HbA1C from baseline, results were reported as: EDITION III: (-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: (-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).
Sanofi is hopeful that these positive outcomes from their phase III trials will help bring U300 to the market in the near future and full research results will be reported in 2014 meetings.
- U300 is a new formulation of insulin glargine that is expected to last up to 40h.
- New phase III study results are showing positive outcomes with U300 performing the same in controlling blood glucose as insulin glargine but with less hypoglycemia during the day and night.
- U300 is based on the glargine molecule but requires a smaller volume of SQ injection and U300 demonstrates a flatter and longer PK/PD profile than that of insulin glargine.
Sanofi Announces New Phase 3 Results for Investigational New Insulin U300 Press Release. Sanofi. December 3, 2013