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Multicenter, Open-Label, 2-Arm, Pilot Trial for Safe Reduction of Basal Insulin Dose Combined with SGLT2 Inhibitor in Type 1 Diabetes Mellitus: Study Protocol for a RISING-STAR Trial.

Yoshitaka HashimotoYoshitaka HashimotoToru TanakaGoji HasegawaMichiyo IshiiHiroshi OkadaKazuteru MitsuhashiNoriyuki KitagawaEmi UshigomeMasahiro YamazakiMichiaki Fukui
Published in: Clinical medicine insights. Endocrinology and diabetes (2021)
In this pilot study, we assumed that, given a sufficient Basal, hypoglycemia would be more frequent in patients with type 1 diabetes when combined with SGLT2 inhibitors, provided the Basal was not reduced.
Keyphrases
  • open label
  • type diabetes
  • phase iii
  • phase ii
  • clinical trial
  • study protocol
  • glycemic control
  • randomized controlled trial
  • cross sectional
  • phase ii study
  • double blind
  • insulin resistance
  • weight loss