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Insulin degludec reduced risk for hypoglycemia in type 2 diabetes
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PHILADELPHIA — Insulin degludec is as safe and effective as insulin glargine in patients with type 2 diabetes and has a lower risk for hypoglycemia, according to data presented here at the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress Meeting.
Insulin degludec forms soluble, multi-hexamers after subcutaneous injections. Researchers said there has been little investigation into the hypoglycemia risk associated with patients using high basal insulin doses of more than 60 U/mL daily. However, phase 3 trials have demonstrated a reduction in hypoglycemia risk compared with insulin glargine. Its “ultra-long, stable action profile with low hour-to-hour and day-to-day variability” could explain its low risk for hypoglycemia, researchers said.
Helena W. Rodbard
Helena W. Rodbard, MD, FACP, researcher and endocrinologist in Rockville, Md., and colleagues designed a meta-analysis that compared glycosylated HbA1c, fasting plasma glucose and rates of overall confirmed and nocturnal confirmed hypoglycemia. Data were observed from a pooled population of patients with type 2 diabetes, using more than 60 U/mL daily of basal insulin at the end of the trial.
“This is a new insulin. It has a very unique pharmacokinetic and pharmacodynamic profile without the typical ups and downs that we see with the other basal insulin, and especially because it does last 24 hours,” Rodbard told Endocrine Today.
“It’s actually the first of the insulins that truly lasts for 24 hours as opposed to some others that disappear after 16, 18, or 20 hours. It’s peakless if you compare it to initial basal insulin such as [neutral protamine Hagedorn], which tended to peak and it worked only about 12 hours.”
Five phase 3A, open-label, randomized, treat-to-target, confirmatory 26-week or 52-week trials with insulin degludec (n=2,262) vs. insulin glargine (n=1,110) administered once daily in patients with type 2 diabetes, were included in the study.
A sizeable percentage of insulin degludec (35.1%) and insulin glargine-administered patients (33.7%) required more than 60 U/mL of basal insulin daily. Researchers said patients obtained similar average HbA1c levels by the end of the trial, and average fasting plasma glucose values were lower with insulin degludec than insulin glargine.
Additionally, there was a 21% lower rate of overall confirmed hypoglycemic episodes for patients using insulin degludec (P=.02), and a 52% lower rate of nocturnal hypoglycemia (measured between the hours of 12 a.m. and 6 a.m.) for insulin degludec (P<.0001).
“I would say it’s very impressive because patients are so concerned about hypoglycemia, and physicians as well,” Rodbard said. – by Samantha Costa
For more information:
- Rodbard HW. Abstract #241. Presented at: the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress Meeting; May 23-27, 2012; Philadelphia.
Disclosure: Dr. Rodbard reports financial ties with Amylin, AstraZeneca, Biodel, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly & Co, Merck & Co, Novartis, Novo Nordisk, Roche Diagnostics, Sanofi and Valeritas.