This article is more than 5 years old. Information may no longer be current.
Three-times weekly long-acting insulin safe, effective
ADA 70th Scientific Sessions
ORLANDO — Insulin degludec, a novel insulin analogue with an ultra-long duration of action, was safe, well tolerated and provided glucose control similar to insulin glargine, researchers said here.
Results of a proof-of-concept trial presented by Bernard Zinman, MD, suggest that insulin degludec may improve compliance among patients with type 2 diabetes by providing a more flexible dosing schedule.
"Degludec insulin is an interesting formulation that forms multiple hexamers, which extends its half-life and is still detectable in the circulation after 96 hours of injection — so it is a remarkably stable basal insulin and there is a current need for better basal insulin," Zinman, director of the Leadership Sinai Center for Diabetes and professor of medicine at University of Toronto, Canada, told Endocrine Today.
The phase 2 trial studied two dose regimens for this of investigational insulin degludec — once-daily and three-times weekly — compared with once-daily insulin glargine (Lantus, Sanofi-Aventis) in 245 insulin-naïve people with uncontrolled type 2 diabetes (mean age, 54.2 years; HbA1c 8.7%). A different degludec formulation was also studied but will not be further developed and the results with this formulation were not presented.
Patients were randomly assigned to one of three regimens, all in combination with metformin. Insulin was injected subcutaneously at night and titrated to achieve fasting plasma glucose levels of 72 mg/dL to 108 mg/dL.
After 16 weeks of treatment, HbA1c was similar across the insulin groups, with a 1.5% reduction in the three-times weekly insulin degludec and insulin glargine groups and a 1.3% reduction in the once-weekly insulin degludec group. Patients achieved a final mean value of 7.3% with once-daily and three-times daily insulin degludec vs. 7.2% with insulin glargine.
Mean FPG and weekly insulin doses were also similar between the three groups.
The majority of adverse events were mild to moderate and similar between groups, ranging from 47% to 66%. The rate of confirmed hypoglycemia appeared lower with the once-daily insulin degludec formulation vs. three-times weekly and insulin glargine (0.6 events vs. 2.3 events vs. 1.1 events).
"To be able to obtain the same lowering of HbA1c with significant increase in hypoglycemia with a three-times per week regimen reinforces the long duration of action of this basal insulin," he said. "The total weekly dose is the same, it is just being delivered less frequently. Whether this particular characteristic will prove to be desirable for patients requires further evaluation in a larger cohort."
Insulin degludec is currently in clinical development by Novo Nordisk. According to the developer, it is a new-generation soluble basal insulin with an ultra-long, peak-less pharmacokinetic profile. - by Katie Kalvaitis
For more information:
- Zinman B. 40-OR. Presented at: The American Diabetes Association 70th Scientific Sessions; June 25-29, 2010; Orlando.
Follow
EndocrineToday.com on Twitter.