Research design
Hypoglycaemia, hypoglycaemia
HYPOGLYCAEMIA, HYPOGLYCAEMIA
This was a randomised, single-centre (Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria), open-label, two-period crossover trial (ClinicalTrials.gov registration no. NCT03945656). The trial was conducted to investigate hypoglycaemia frequency and the response to hypoglycaemia following icodec and glargine U100 administration at double and triple dose levels. Hypoglycaemia frequency was assessed based on all participants, while the response to hypoglycaemia was assessed in a subgroup analysis based on individuals who actually experienced hypoglycaemia after a double or triple insulin dose, i.e. those with a PG decline to <3.0 mmol/l and/or the presence of hypoglycaemic symptoms.The protocol was reviewed and approved by appropriate health authorities according to local regulation, and by the Independent Ethics Committee of the Medical University of Graz. The trial was performed in accordance with the Declaration of Helsinki and Good Clinical Practice. Prior to any trial-related activities, participants provided written informed consent.