Meta-analysis: Insulin degludec did not increase risk for recurrent hypoglycemia

SAN FRANCISCO — Results of a post-hoc meta-analysis of trials comparing insulin degludec with insulin glargine demonstrate that degludec was associated with a 27% lower rate of recurrent hypoglycemia vs. glargine in patients with type 2 diabetes treated with basal-bolus therapy. Additionally, insulin degludec did not increase the risk among those treated with oral medications.

Thue Johansen, MD, of Novo Nordisk A/S in Soborg, Denmark, presented results during an oral presentation here. He and colleagues, including Alan J. Garber, MD, PhD, Endocrine Today Chief Medical Editor, conducted a meta-analysis of five phase 3a, randomized, intention-to-treat trials comparing once-daily insulin degludec (n=2,262) with insulin glargine (n=1,110) in patients with type 2 diabetes. Four trials compared degludec with glargine in combination with oral antidiabetic therapies, and one trial compared the two insulins in basal-bolus therapy with mealtime insulin aspart. They defined recurrent confirmed hypoglycemia (plasma glucose <56 mg/dL or severe) as pairs of episodes occurring within 24 hours of each other.

Alan J. Garber

In the basal-bolus trial, 38% of patients assigned to insulin degludec and 43% of those assigned to insulin glargine experienced recurrent hypoglycemia, compared with 6.1% of those assigned insulin degludec and 6.6% of those assigned insulin glargine in the four oral therapy trials.

There was no statistically significant difference in the rate of confirmed hypoglycemia between the two insulin groups among the entire meta-analysis population (estimated rate ratio [ERR] for degludec/glargine: 0.82; P=.09) or the oral medication population (ERR: 0.92; P=.70). In the basal-bolus trial, however, insulin degludec was associated with a 27% lower rate of recurrent confirmed hypoglycemia vs. insulin glargine (ERR: 0.73; P=.04).

“Insulin degludec, which has a very consistent profile and a long profile of action, despite this novel profile of action, is not associated with an increased risk for recurrent hypoglycemic events within 24 hours, which is the answer to the main question of this work,” Johansen said. “In the basal oral therapy trials you can see the risk is very similar, but in the basal-bolus trials it is significantly reduced.” – by Stacey L. Adams

For more information:

Garber AJ. #OR49-1. Presented at: The Endocrine Society Annual Meeting and Expo; June 15-18, 2013; San Francisco.

Disclosures: Garber is on the speaker bureau for Jansen Pharmaceuticals, Santarus, Merck and Co., Daiichi Sankyo and Novo Nordisk. He is also a consultant for Halozyme, Vivus USA, Lexicon Pharmaceuticals, Tethys, Boehringer Ingelheim, LipoScience, Takeda, Santarus, Merck and Co., Daiichi Sankyo. He is an advisory group member for Novo Nordisk, Daiichi Sankyo, Merck and Co., Takeda, LipoScience, Boehringer Ingelheim, Halozyme and Novo Nordisk. Johansen is an employee of Novo Nordisk.