Three Times a Week Insulin Degludec Not As Effective

Two phase 3 trials were conducted to examine the extent of blood glucose control with triweekly dosing vs once daily dosing of insulin degludec. Researchers found that type 2 diabetes patients has less control with triweekly dosing and a greater risk for hypoglycemia compared with once daily dosing of insulin glargine. These two trials recommend that since the risks are greater than the benefits with three times a week dosing that basal insulin should be taken once daily for the best results.

Author Bernard Zinman, MD of Samuel Lunenfeld Research Center and University of Toronto, said, "I was very anxious that these two phase 3 studies get published, because they don’t support the phase 2 study that suggested the benefit of triweekly dosing."

Degludec has been approved for once daily dosing in Japan, Mexico, and Europe to treat both type 1 and type 2 diabetes. It is a long acting basal insulin that lasts for 42 hours within the body. A previous phase 2 trial showed that when insulin degludec was given to type 2 diabetic patients three times a week, that it "seemed to work" as well as once daily insulin. The data from this study lead to two large, 26 week phase 3 studies.

Researchers found that insulin degludec did not provide at least a 0.4% great decrease in HbA1c levels. These trials showed that the number of hypoglycemic episodes was 2 to 3 times larger with insulin degludec in the first 24 hours. This implies that after insulin degludec is injected, it peaks in concentration within 24 hours and then slowly declines and provides blood glucose control until the next dose is administered.

Dr. Zinman said, "I don’t think the company is trying to approve it anywhere for anything less than once a day. It’s clearly much better when it’s used once a day."

The Lancet Diabetes & Endocrinology, Early Online Publication, 9 July 2013doi:10.1016/S2213-8587(13)70013-5