Overlapping risk factors for diabetic ketoacidosis in patients with type 1 diabetes on ipragliflozin: case analysis of spontaneous reports in Japan from a pharmacovigilance safety database

Abiru, Norio; Nakatsuji, Yoshino; Noguchi, Masahiro; Tsuboi, Keigo

doi:10.1080/14740338.2023.2193393

Cited by 3 publications

(2 citation statements)

References 27 publications

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“…Recent realworld data of Japanese individuals with T1D treated with ipragliflozin revealed that DKA events were associated with several overlapping factors, including sick days and a reduced dose or interruption of insulin. 41 Our study has several limitations. The sample size was small, and we could not exclude a possibility that the premature dropouts…”

Section: Discussionmentioning

confidence: 91%

“…Elevated glucagon under ipragliflozin treatment might accelerate hyperketonaemia with inappropriate insulin therapy. Recent real‐world data of Japanese individuals with T1D treated with ipragliflozin revealed that DKA events were associated with several overlapping factors, including sick days and a reduced dose or interruption of insulin 41 …”

Section: Discussionmentioning

confidence: 99%

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Glucagon secretion and its association with glycaemic control and ketogenesis during sodium‐glucose cotransporter 2 inhibition by ipragliflozin in people with type 1 diabetes: Results from the multicentre, open‐label, prospective study

Nakamura,

Horie,

Kitamura

et al. 2024

Diabetes Obesity Metabolism

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AimClinical trials showed the efficacy of sodium‐glucose cotransporter 2 inhibitors for type 1 diabetes (T1D) by significant reductions in body weight and glycaemic variability, but elevated susceptibility to ketoacidosis via elevated glucagon secretion was a potential concern. The Suglat‐AID evaluated glucagon responses and its associations with glycaemic control and ketogenesis before and after T1D treatment with the sodium‐glucose cotransporter 2 inhibitor, ipragliflozin.MethodsAdults with T1D (n = 25) took 50‐mg open‐labelled ipragliflozin daily as adjunctive to insulin. Laboratory/clinical data including continuous glucose monitoring were collected until 12 weeks after the ipragliflozin initiation. The participants underwent a mixed‐meal tolerance test (MMTT) twice [before (first MMTT) and 12 weeks after ipragliflozin treatment (second MMTT)] to evaluate responses of glucose, C‐peptide, glucagon and β‐hydroxybutyrate.ResultsThe area under the curve from fasting (0 min) to 120 min (AUC0‐120min) of glucagon in second MMTT were significantly increased by 14% versus first MMTT. The fasting and postprandial β‐hydroxybutyrate levels were significantly elevated in second MMTT versus first MMTT. The positive correlation between postprandial glucagon secretion and glucose excursions observed in first MMTT disappeared in second MMTT, but a negative correlation between fasting glucagon and time below range (glucose, <3.9 mmol/L) appeared in second MMTT. The percentage changes in glucagon levels (fasting and AUC0‐120min) from baseline to 12 weeks were significantly correlated with those in β‐hydroxybutyrate levels.ConclusionsIpragliflozin treatment for T1D increased postprandial glucagon secretion, which did not exacerbate postprandial hyperglycaemia but might protect against hypoglycaemia, leading to reduced glycaemic variability. The increased glucagon secretion might accelerate ketogenesis when adequate insulin is not supplied.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%