That was the question addressed in a recent review published in the BMJ Open Diabetes Research & Care. Researchers from the Velocity Clinical Research at Medical City and colleagues sought to determine the answer to help address the emerging theoretical concern of increased hypoglycemic risk with once-weekly basal insulin.
To do that, the study team extracted hypoglycemia data from treat-to-target, randomized clinical trials conducted from 2000 to 2022. The published articles were identified on PubMed or were within the FDA submission documents.
Ultimately, the researchers identified 57 articles, with 44 assessing hypoglycemic outcomes in participants receiving basal insulin–only therapy. Of those, 33 involved insulin-naïve participants and 11 involved insulin-experienced participants. Of the others, four investigated a mixed population (insulin-naive and insulin-experienced participants), and nine were conducted with participants receiving basal-bolus therapy.
The emphasis of the analysis was level 2 (blood glucose <3.0 mmol/L [<54 mg/dL]) and level 3 (severe) hypoglycemia.
“Overall, event rates for level 2 or level 3 hypoglycemia across most studies ranged from 0.06 to 7.10 events/person-year of exposure (PYE) for participants receiving a basal-only insulin regimen; the rate for basal-bolus regimens ranged from 2.4 to 13.6 events/PYE,” the authors reported. “Rates were generally lower with second-generation basal insulins (insulin degludec or insulin glargine U300) than with neutral protamine Hagedorn insulin or first-generation basal insulins (insulin detemir or insulin glargine U100).”
The authors added that subgroup categorization by sulfonylurea usage, end-of-treatment insulin dose, or glycated hemoglobin reduction “did not show consistent trends on overall hypoglycemia rates. Hypoglycemia rates reported so far for once-weekly basal insulins are consistent with or lower than those reported for daily-administered basal insulin analogs.”
A recent article in BioMedicines suggested that once-weekly basal insulin administration would reduce clinical inertia, increase treatment adherence, and improve patients’ quality of life, as long as the risk of hypoglycemia remains low.
he Italian researchers wrote, “Although the currently available basal insulin formulations are effective and have a reduced hypoglycemic risk compared to past formulations, their therapeutic introduction could be more timely, mainly due to clinical inertia, patient concerns and poor compliance and education by medical personnel. Poor adherence to daily dosing is widespread and associated with poor glycemic control.”
The researchers added that “the research has moved towards developing basal insulin with longer than twenty-four hours of action and a flatter insulin profile.”
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