Sanofi's next-generation insulin U300 (insulin glargine 300 U/mL), an updated version of its blockbuster Lantus (insulin glargine 100 U/mL), has hit targets in a Phase III clinical trial programme assessing its potential in diabetes.
Further data from the EDITION programme were unveiled at the American Diabetes Association meeting in San Francisco, including a pooled analysis from three Phase III trials investigating U300 in patients with type 2 diabetes, which consistently showed fewer low blood sugar events at any time of day, including night-time events, when compared with Lantus.
Furthermore, full results from the EDITION III trial showed fewer U300 patients experienced hypoglycaemic events during the initial eight-week insulin titration period versus its predecessor.
Many people go through a sensitive phase when starting insulin and they tend to drop treatment or not properly up-titrate when exposed to hypoglycaemia, said Geremia Bolli, Professor of Endocrinology, University of Perugia, Italy, stressing that "reducing hypoglycaemic events in this particular phase is relevant in helping patients better manage diabetes".
Fewer people with type 2 diabetes, who were new to insulin treatment, experienced night-time hypoglycaemia when treated with U300 versus Lantus, but this effect was not replicated overall in a separate trial (EDITION IV) in patients with type I forms of the disease, apart from during the eight-week titration phase.
Lantus will lose its patent protection over the next couple of years, and Sanofi has high hopes it can be replaced by U300, which is currently being reviewed regulators in Europe.
Meanwhile, Sanofi and Medtronic said they have formed a strategic alliance in diabetes to improve patient experience and outcomes.
The companies have signed a 'memorandum of understanding' for an open-innovation relationship, which will leverage both parties' capabilities and resources.
The alliance will pair Sanofi's insulin portfolio and drug development know-how with Medtronic's expertise in insulin pumps and continuous glucose monitoring, with a particular priorate being novel drug-device combinations that are affordable and easy to use.