medwireNews: Head-to-head trials of the ultralong-acting insulin degludec versus insulin glargine U100 show that the former significantly reduces the risk for hypoglycemia in patients with type 1 and type 2 diabetes.
The SWITCH studies, both published in JAMA, assigned patients to receive each study medication for a 16-week titration period followed by a 16-week maintenance period, in a randomized order.
In SWITCH 1, which included 501 patients with type 1 diabetes, hypoglycemia occurred at rates of 2200.9 versus 2462.7 episodes per 100 person–years of exposure during the degludec and glargine periods, respectively, equating to a significant 11% reduction with degludec.
Degludec treatment was also associated with a significant reduction in nocturnal hypoglycemia, at 277.1 versus 428.6 episodes per 100 person–years of exposure, and a significantly lower proportion of patients with severe hypoglycemic episodes during the maintenance period, at 10.3% versus 17.1%.
In both trials, hypoglycemia was defined as blood glucose less than 56 mg/dL and/or requiring the assistance of another person to take corrective measures; the latter was also the definition of severe hypoglycemia.
Editorialists Elizabeth Seaquist and Lisa Chow, both from the University of Minnesota in Minneapolis, USA, note that the overall hypoglycemia definition will make it hard to compare the SWITCH trials with future research, given that current guidelines also count asymptomatic episodes with blood glucose below 54 mg/dL.
“The rationale is that glucose levels less than 54 mg/dL are associated with impaired cognitive function and predict cardiac arrhythmias and mortality,” they say, as well as being an indicator of impaired hypoglycemia awareness.
SWITCH 2 involved 720 patients with type 2 diabetes requiring basal insulin. Although the overall rate of hypoglycemia was much lower than in SWITCH 1, its incidence was nonetheless significantly reduced with degludec versus glargine, at 185.6 versus 265.4 episodes per 100 person–years of exposure, giving a 30% reduction.
Again, nocturnal hypoglycemia was reduced, at 55.2 versus 93.6 episodes per 100 person–years of exposure, although the reduction in the proportion of patients with a severe hypoglycemic episode during the maintenance period was not statistically significant, at 1.6% versus 2.4%.
In both studies, glycemic control was equally good with both insulins, report the researchers – Wendy Lane (Mountain Diabetes and Endocrine Center, Asheville, North Carolina, USA) and colleagues for SWITCH 1, and Carol Wysham (Rockwood Clinic, University of Washington School of Medicine, Spokane, USA) and team for SWITCH 2.
In their editorial, Seaquist and Chow note that the study insulins “were titrated using a set protocol that probably exceeds common clinical practice, so cautious clinicians may want to see the results of a more pragmatic trial.”
But they add: “Given the risks associated with hypoglycemia and the negative consequences that concerns about hypoglycemia have for patients and their families, any basal insulin associated with a reduced rate of hypoglycemia would seem to represent an advance in therapy.”
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