Sanofi Posts U300 Results

Sanofi has posted the full results from the EDITION II study showing that its investigational new insulin, U300, demonstrated similar blood sugar control with 23% fewer patients experiencing night-time low blood sugar compared with Lantus (insulin glargine [rDNA origin] injection).

The results were presented at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia. The full EDITION II results are consistent with those from EDITION I. Both studies were conducted in people with type 2 diabetes already using basal insulin (with mealtime insulin or oral medication).

Sanofi also announced additional topline results from the EDITION Phase III clinical program. The primary endpoint was met in the six-month EDITION III, EDITION IV and EDITION JP I studies. Full results will be presented at scientific meetings in 2014.

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. The study randomized 811 participants to U300 or Lantus 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 six months in people with type 2 diabetes who had challenging baseline characteristics. The percentage of participants with severe or confirmed night-time low blood sugar levels (nocturnal hypoglycemia) from month 3 to 6 was significantly lower with U300 vs. Lantus. During the six-month treatment period, the incidence of any nocturnal hypoglycemia was lower with U300 vs. Lantus as was the incidence of any hypoglycemic event at any time of the day (over a 24-hour period). This result was also obtained across the entire 6-month study period, including the first eight weeks of the trial.

There were similar findings between groups for adverse events, including injection site reactions and hypersensitivity reactions.

U300 is a new formulation based on the glargine molecule, the biological entity of Lantus, which has a well established efficacy and safety profile. U300 has unique pharmacokinetic and pharmacodynamic profiles, with studies demonstrating it has flatter and more prolonged profiles than Lantus. U300 also offers the benefit of a smaller volume of subcutaneous injection compared with Lantus.