OR49-1 Rate of Recurrent Confirmed Hypoglycemia with Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: OR49-Insulin Therapy: Glycemic Control & Hypoglycemia
Clinical
Tuesday, June 18, 2013: 9:15 AM-10:45 AM
Presentation Start Time: 9:15 AM
Room 307 (Moscone Center)
Alan J Garber*1, Marc Evans2, Lars Bardtrum3, Thue Johansen3 and Simon Heller4
1Baylor Coll of Med Faculty Ctr, Houston, TX, 2Llandough Hospital, Cardiff, United Kingdom, 3Novo Nordisk A/S, Søborg, Denmark, 4University of Sheffield, Sheffield, United Kingdom
Background
Insulin degludec (IDeg) is a new basal insulin with an ultra-long and stable glucose-lowering effect (>42 hours) with low within-patient variability.

With any long-acting insulin there is a potential concern that an extended action profile may increase the risk of recurrent hypoglycemia, which can lead to hypoglycemia unawareness and a reduction in the counterregulatory response to subsequent hypoglycemia. We have previously reported data from a prospective meta-analysis of phase 3a trials that showed IDeg to be associated with significantly lower rates of discrete episodes of confirmed hypoglycemia (by 17%) and nocturnal confirmed hypoglycemia (by 32%) vs. insulin glargine (IGlar) in patients with type 2 diabetes (T2D).

In this post-hoc meta-analysis of patients with T2D, we compared IDeg and IGlar with respect to rates of recurrent confirmed hypoglycemia.

Methods
The patient-level meta-analysis included all five phase 3a, randomized, treat-to-target trials (26 or 52 week) in which once-daily IDeg (n=2,262) and IGlar (n=1,110) have been compared in patients with T2D. All trials were open-label. One trial (BB trial) compared IDeg with IGlar in basal–bolus therapy with mealtime insulin aspart; all other trials compared IDeg and IGlar in combination with oral antidiabetic therapy (BOT trials). BB and BOT trials were analyzed independently. Recurrent confirmed hypoglycemia (PG <56 mg/dL or severe) was defined as pairs of episodes that occurred within 24 hours of one another, and was analyzed using a negative binomial model.

Results
Overall, 38% (IDeg) and 43% (IGlar) of patients experienced recurrent hypoglycemia in the BB trial, compared with 6.1% (IDeg) vs. 6.6% (IGlar) of patients in the four BOT trials combined.

No statistically significant difference in rates of recurrent confirmed hypoglycemia were found between IDeg and IGlar for the overall meta-analysis population (estimated rate ratio (ERR) IDeg/IGlar: 0.82 [0.65; 1.03], p=0.09) or the BOT population (ERR: 0.92 [0.62; 1.38], p=0.70). For the BB trial, a significant, 27% lower rate of recurrent confirmed hypoglycemia was found for IDeg vs. IGlar (ERR: 0.73 [0.54; 0.99], p=0.04).

Conclusion
Despite having a longer duration of action than IGlar, IDeg is not associated with an increased risk of developing a new confirmed hypoglycemic episode within 24 hours of a previous episode in T2D patients treated with BOT, and was observed to have a reduced risk in patients treated with BB therapy.

Disclosure: AJG: Speaker Bureau Member, Jansen Pharmaceuticals, Speaker Bureau Member, Santarus, Speaker Bureau Member, Merck & Co., Speaker Bureau Member, Daiichi Sankyo, Speaker Bureau Member, Novo Nordisk, Consultant, Halozyme, Consultant, Vivus USA, Consultant, Lexicon Pharmaceuticals, Inc., Consultant, Tethys, Consultant, Boehringer Ingelheim, Consultant, LipoScience, Consultant, Takeda, Consultant, Santarus, Consultant, Merck & Co., Consultant, Daiichi Sankyo, Advisory Group Member, Novo Nordisk, Advisory Group Member, Daiichi Sankyo, Advisory Group Member, Merck & Co., Advisory Group Member, Takeda, Advisory Group Member, LipoScience, Advisory Group Member, Boehringer Ingelheim, Advisory Group Member, Halozyme, Consultant, Novo Nordisk. ME: Speaker, Sanofi, Speaker, Novo Nordisk, Advisory Group Member, Merck & Co., Advisory Group Member, Novartis Pharmaceuticals, Advisory Group Member, Sanofi, Advisory Group Member, Novo Nordisk, Speaker, Novartis Pharmaceuticals, Speaker, Merck & Co.. LB: Employee, Novo Nordisk, Employee, Novo Nordisk. TJ: Employee, Novo Nordisk, Employee, Novo Nordisk. SH: Advisory Group Member, Lifescan Inc, Advisory Group Member, Takeda, Consultant, Eli Lilly & Company, Consultant, Novo Nordisk, Consultant, Amylin Pharmaceuticals, Consultant, Sanofi, Speaker Bureau Member, Eli Lilly & Company, Speaker Bureau Member, Novo Nordisk, Speaker Bureau Member, Abbott Laboratories, Advisory Group Member, Novo Nordisk, Advisory Group Member, Eli Lilly & Company, Speaker Bureau Member, Merck Sharp & Dohme.

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

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