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AACE: Degludec Shows Efficacy in Type 1 Diabetes

May 9, 2013

Type 1 diabetes patients had lower rates of nocturnal hypoglycemia with once-daily doses of insulin degludec versus similar doses of insulin glargine….

According to Helena Rodbard, MD, a private practice endocrinologist in Washington, D.C., and past president of the American Association of Clinical Endocrinologists, and colleagues, during overnight hours, patients receiving insulin degludec had significantly lower rates of nocturnal confirmed hypoglycemia over the full trial by 36% and by 44% in the maintenance period P=0.033) compared with those receiving insulin glargine.

Rates of overall confirmed hypoglycemia between insulin degludec and insulin glargine did not differ significantly over the full trial and maintenance periods.

Insulin degludec is a new basal insulin "with an ultra-long and stable glucose-lowering effect" that is not currently indicated for treatment of patients with type 1 diabetes.

Previous phase III trials comparing insulin degludec and insulin glargine in type 1 diabetes patients showed a 17% lower rate of nocturnal confirmed hypoglycemia over the treatment period and a significant 25% lower rate of nocturnal confirmed hypoglycemia during the trial maintenance period (P<0.05), the authors wrote.

The analysis compared hypoglycemia rates in two open-label, randomized studies between the two insulins in type 1 diabetes patients at high, once-daily doses in a population of 950 patients who received 0.45 U/kg of insulin degludec or insulin glargine or greater at the end of the studies.

Researchers measured HbA1c, fasting plasma glucose, and hypoglycemia over the trial periods and after a 16-week maintenance period after dosing stabilized. Instance of hypoglycemia was measured overall and as a nocturnal confirmed measure.

Concentrations of HbA1c were similar between groups by end of trial (7.4% for insulin degludec versus 7.8% for insulin glargine), as were rates of fasting plasma glucose (133 mg/dL versus 136 mg/dL).

Overall rates of hypoglycemia did not differ significantly between treatment groups. However, there was a significant superiority for insulin degludec in nocturnal confirmed hypoglycemia during and after the trial in those treated with greater than 0.45 U/kg doses.

All patients treated with insulin degludec — including those treated with quantities smaller than 0.45 U/kg — also significantly outperformed those treated with insulin glargine during the maintenance period (RR 0.75, 95% CI 0.60 to 0.94).

Rodbard added that, these results confirm that, "insulin degludec is a well-tolerated and effective basal insulin choice for patients with type 1 diabetes across the spectrum of insulin requirements."

Robert Zimmerman, MD, co-chair of AACE who was not involved in the study, added that the improvements in nocturnal confirmed hypoglycemia are important because it is difficult to address such symptoms due to patients being asleep.

At this time it is not FDA approved in the U.S.

Practice Pearls:

  • Be aware that no differences in terms of hemoglobin A1C or overall glucose control were noted.
  • This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • Note that this meta-analysis of randomized trials demonstrates that insulin degludec has more favorable nocturnal hypoglycemia rates than insulin glargine in type 1 diabetics.

Rodbard H, et al "Reduced risk of nocturnal confirmed hypoglycemia with insulin degludec versus insulin glargine in patients with type 1 diabetes requiring high doses of basal insulin: a meta-analysis of five randomized trials" AACE 2013; Abstract 279.