|Sanofi presented head-to-head trial results for Toujeo Monday.|
Sanofi’s diabetes injection Toujeo showed non-inferiority to Novo Nordisk’s Tresiba in a head-to-head trial that looked at how the therapies lower hypoglycemia rate and incidence in patients with type 2 diabetes.
Hypoglycemia, more commonly known as low blood sugar, occurs when blood sugar drops to below normal levels resulting in symptoms such as clumsiness, trouble talking, confusion, and loss of consciousness. It may also lead to seizures or death.
"Hypoglycemia is a concern for people with diabetes, particularly in the initial period of dose adjustment," says Alice Cheng, associate professor of endocrinology, University of Toronto, Canada, and a primary investigator of the study. "Experiencing hypoglycemia, particularly in this early treatment period, could lead to patients discontinuing their treatment."
The findings of the BRIGHT study were presented at the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, Florida.
The 24-week study of Toujeo (insulin glargine) versus Tresiba (insulin degludec) compared the safety and efficacy of the two drugs in a randomized controlled trial on 929 adults with type 2 diabetes.
Patients either took a once-daily Toujeo or insulin degludec 100 Units/mL. These patients were inadequately controlled with oral antihyperglycemic drugs (OADs), with or without a glucagon-like peptide-1 (GLP-1) receptor agonist and had no experience with insulin therapy.
The study met its primary endpoint by demonstrating a reduction in blood sugar (HbA1c) levels and was non-inferior to insulin degludec in adults with type 2 diabetes not previously on insulin.
The first 12 weeks of the study - called the titration period where patients and physicians work to determine the appropriate insulin dose – confirmed rates of “significant” hypoglycemia events (≤54 mg/dL) were reduced by 43 percent. Rates of “mild” hypoglycemia events (≤70 mg/dL) were also lowered by 23 percent.
During the 12-week period, significant hypoglycemia incidence also dropped 37 percent while mild hypoglycemia incidence fell 26 percent.
During the second 12 weeks of the study (week 13-24), or the maintenance period, the two treatments showed similar incidence and rate of hypoglycemic events, according to Sanofi.
The incidence of low blood sugar at any time of the day during the 24-week treatment period was also comparable between Toujeo and insulin degludec (66.5 percent and 69 percent).