Ultra-Long-Acting Insulin Degludec, Two New Studies

Two published Phase III studies reveal that ultra-long-acting insulin degludec considerably reduced rates of nocturnal hypoglycemia in patients with type 1 and type 2 diabetes by 25%, compared to insulin glargine.

"Hypoglycemia is a major concern for both people with diabetes and their physicians and can often lead to under- and sub-optimal treatment," said Alan Garber, MD, Professor, Departments of Medicine, Baylor College of Medicine, Houston, Texas and lead author of one of the published papers in The Lancet. "Of particular concern are hypoglycemic events that occur in the overnight hours during sleep when patients are unaware and therefore unable to take measures to reverse it. Newer insulins such as insulin degludec may be able to mitigate this concern."

1,635 individuals with diabetes were enrolled to participate in the trials in order to examine insulin degludec, compared to insulin glargine, in a basal-bolus regimen.

In both studies, researchers adjusted patient insulin doses systematically in order to allow them to achieve a targeted fasting glucose level. Due to this, participants in both studies successfully achieved similar improvements in sugar control. This allowed the researchers to closely determine disparity in hypoglycemia rates.

Dr. Garber, stated that, the studies found that participants with type 2 diabetes who took insulin degludec had a considerably lower rate of overall hypoglycemic events (11.1 episodes/patient-year), compared to individuals assigned to insulin glargine (13.6). This figure was similar between both groups in individuals with type 1 diabetes.

Furthermore, results showed that insulin degludec reduced nocturnal hypoglycemia by 25% in both type 1 and type 2 diabetes (4.4 vs. 5.9 episodes/patient-year), compared to participants taking insulin glargine (1.4 vs. 1.8).

Insulin degludec is an ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow absorption which provides a flat and stable action profile. Insulin degludec has been studied in a large-scale clinical trial program, BEGIN™, examining its impact on glucose control, hypoglycemia and the possibility to flexibly adjust insulin degludec dosing time to suit patient needs. Insulin degludec has been submitted for once-daily use to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September 2011 for regulatory review. In addition, insulin degludec has been submitted for regulatory approval in Japan, Canada and Switzerland.

The Lancet. 2012; 379, pp 1489-97: "Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial"