Secondary outcomes
seizure, hypoglycaemia
SECONDARY, HYPOGLYCAEMIA
The following secondary outcomes were assessed: Tolerability, defined as taking the drug for at least 12 weeks.Participant reported side effects, assessed at the end of each treatment period (see Weight on each therapy, measured at the end of each treatment period.Participant reported experience of hypoglycaemia at the end of each treatment period (binary variable: experienced at least one episode of hypoglycaemia v none). Low blood glucose was defined as either ‘episodes of hypoglycaemia where you felt confused, disorientated or lethargic, and were unable to treat yourself’ or ‘hypoglycaemic episodes where you were unconscious or had a seizure and needed glucagon or intravenous glucose’. At both baseline and subsequent time points, number of episodes, or experience of hypoglycaemia was self-reported and collected on data collection forms.Patient preference of therapy. Participants ranked the three drugs in overall preference, 1 for most preferred, 3 for least preferred.In line with a change to the statistical analysis plan that we specified prior to data lock, analysis and unblinding, we did not analyse gender differences as a secondary outcome as our study was powered for a 60:40 split in strata, whereas 73% of our cohort were male.