Participants
diabetes complications, kg/mBased, type 2 diabetes, hypoglycaemia
TYPE 2 DIABETES, CARDIOVASCULAR DISEASE, HYPOGLYCAEMIA
Potential participants were recruited based on the site’s database of individuals with type 2 diabetes, advertisements in printed and electronic media including social media reaching the broad Austrian population, and referrals from general practitioners and specialists in internal medicine.Eligible participants were men or women aged 18–72 years, diagnosed with type 2 diabetes for ≥180 days before screening, treated with basal insulin (total daily insulin dose of 0.2–1.0 U/kg) with or without oral glucose-lowering drugs (metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 inhibitors and sodium–glucose cotransporter 2 inhibitors were allowed) ≥90 days before screening, with a BMI of 18.5–37.9 kg/mBased on the eligibility criteria, the trial population was a selection of the broad type 2 diabetes population, i.e. being treated with basal insulin with or without oral glucose-lowering drugs and with no clinically significant diabetes complications and no history of cardiovascular disease. The latter criterion was chosen due to the burdensome nature of the trial owing to the induced hypoglycaemia element of the study. Thus, the participant selection was balanced between including the target population of basal insulin users and assuring an acceptable risk with the trial intervention. The enrolled participants were considered representative of the target trial population with respect to sex, age and race.