Sanofi’s newest insulin, Toujeo, met its primary objective in a large head-to-head trial that compared it with its chief competitor, Novo Nordisk’s Tresiba, according to a statement from Sanofi released Monday
The BRIGHT study compared insulin glargine 300 units/mL (Toujeo) with insulin degludec (Tresiba), in patients with type 2 diabetes who had uncontrolled glycated hemoglobin (A1C) while taking oral glucose-controlling therapies, with or without a glucagon-like peptide-1 (GLP-1) receptor agonist. The study followed 929 adults with uncontrolled T2D.
Full results of the BRIGHT study will be presented in 2018, the statement said.
In the study, the primary objective was to determine if the effect of Toujeo on A1C was similar to Tresiba, according to the statement from Sanofi. Secondary objective included the share of patients who experience adverse events, the number of patients who experience hypoglycemia during the study, and the rate of hypoglycemic events.
Researchers also asked patients about their use of rescue therapy and recorded patient-reported outcomes using the Diabetes Treatment Satisfaction Questionnaire and the Hypoglycemic Attitudes and Behavior Scale.
The study comes amid a movement with the diabetes research and advocacy community to work with FDA to use clinical measures besides A1C in the approval process, with the possibility that these measures might be incorporated into a product label. A recent paper
published in Diabetes Care
calls for consideration to be given to the ability of drugs and devices to prevent hypoglycemia, to improve time in range and to prevent diabetic ketoacidosis.
“The most recently introduced long-acting insulins have already demonstrated significant blood glucose lowering benefit to adult patients with diabetes,” said Riccardo Perfetti, head of Global Diabetes Medical Team, Sanofi, in the statement. "From the perspective of physicians and patients, hypoglycemia remains a major limiting factor in effective blood sugar management in diabetes. We believe that these first comparative clinical data assessing similarity and difference not only in efficacy, but also in the important safety aspect, such as low blood sugar events, can support physicians in their treatment decisions. We look forward to release of the full results of the study.”