To clarify the frequency of
hypoglycemia in patients with
type 1 diabetes mellitus receiving
dapagliflozin combination
therapy to reduce their basal
insulin dose. Sixty subjects were assigned to two groups according to their basal
insulin-to-total daily dose (
TDD) ratio: group A (basal
insulin/
TDD <40%) and group B (≥40%). Reduction of the basal
insulin dose was instituted in group B, but not in group A. The number of
hypoglycemic events per day and
ketosis frequency were the primary and secondary endpoints, respectively. The
hypoglycemia frequency before and after the intervention was 0.23 and 0.26 times/day in group A and 0.19 and 0.23 times/day in group B, respectively, with no significant difference between the groups. The total
insulin dose reduction was approximately 10% in both groups.
Ketosis frequency increased significantly after the intervention (from 0.013 to 0.086 times/day in group A and 0.013 to 0.059 times/day in group B). Time-in-range, mean amplitude of glycemic excursion, and
glycated hemoglobin A1c improved in both groups. No significant difference in
hypoglycemia frequency was observed between patients with and without reduction of the basal
insulin dose. The combination
therapy improved
glycemic control and patient satisfaction regarding
hyperglycemia. Nevertheless, adequate attention to
ketosis is crucial.