During the first 12 weeks of study, the investigated therapy had also reduced patient hypoglycemia event rates by 23% and low blood sugar event rates by 26% versus comparative therapy.
Alice Cheng, MD
Sanofi has presented new data reporting positive non-inferiority of long-acting insulin glargine injection (Toujeo) compared to insulin degludec (Tresiba) for treatment of blood sugar (HbA1c) and hypoglycemia in adults with type 2 diabetes (T2D).
The results of the BRIGHT study, presented at the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, FL, detailed insulin glargine’s comparable efficacy and safety to competitor insulin degludec at 24 weeks. A total of 929 adults with T2D were randomized to once-daily 300 U/mL insulin glargine or degludec, after having failed adequate T2D control with oral anti-hyperglycemic drugs, glucagon-like peptide-1 (GLP-1) receptor agonist. Patients were also required to have not started previous insulin therapy.
Over 24 weeks, patients administered insulin glargine met the primary endpoint of non-inferiority HbA1c level reduction versus patients administered degludec from baseline (0.3% difference; 95% CI; -0.15 - 0.05%).
During the first 12 weeks of study — serving as the titration period — the investigated therapy had also reduced patient hypoglycemia event rates by 23% and low blood sugar event rates by 26% versus comparative therapy (P < 0.05). Low blood sugar incidence at any time of the day during the entire 24-week trial also reported comparable results between insulin glargine (66.5%) and insulin degludec (69.0%).
Toujeo, a therapy approved by the US Food and Drug Administration (FDA) as a blood sugar control in patients with diabetes mellitus, contains 3 times as much insulin in 1 mL as standard insulin (300 Units/mL).
Previously at ADA, Tresiba maker Novo Nordisk released retrospective data from the 4000-patient real-world CONFIRM trial. The analysis showed that 2 different doses of Tresiba significantly lowered glycated hemoglobin levels in patients with T2D that was uncontrolled by oral antidiabetics or GLP-1 receptor agonists.
In response to the newly reported BRIGHT results, Alice Cheng, MD, primary investigator and associate professor of Endocrinology, University of Toronto, noted the standout data from the trial being in early hypoglycemia control.
"Hypoglycemia is a concern for people with diabetes, particularly in the initial period of dose adjustment," Cheng said. "Experiencing hypoglycemia, particularly in this early treatment period, could lead to patients discontinuing their treatment."
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