Treatment periods
hypoglycaemia
HYPOGLYCAEMIA
During the two treatment periods, participants received once-weekly icodec for 6 weeks or once-daily glargine U100 for 11 days in randomised order. The difference in treatment duration between icodec and glargine U100 was due to the difference in dosing frequencies and, hence, time to steady state, since hypoglycaemia induction following double and triple doses was performed at steady state. Treatment periods were separated by 35–49 days of washout following icodec and 4–11 days of washout following glargine U100. Icodec (4200 nmol/ml; Novo Nordisk, Bagsværd, Denmark) was administered s.c. in the left thigh at 20:00 hours by qualified site staff using a NovoPen 4 pen injector (Novo Nordisk). A normal dose of once-weekly icodec was defined as seven times the individual basal once-daily glargine U100 dose established during run in; hence, the total weekly dose was equal for both insulin products. At the start of week 1, a one-time additional 100% icodec dose was administered to accelerate time to steady state, followed by a normal dose at week 2, a double dose at week 3 (prior to hypoglycaemia induction), no dose at week 4 (due to the double dose given the week before), a normal dose at week 5, and a triple dose at week 6 (prior to hypoglycaemia induction). Insulin glargine U100 (100 U/ml [600 nmol/ml]; Sanofi, Paris, France) was administered s.c. in the right thigh at 09:00 hours by qualified site staff using a SoloStar pen injector (Sanofi). A normal dose of once-daily glargine U100 was established during run in. Glargine U100 was administered at a normal dose for 3 days followed by a double dose on day 4 (prior to hypoglycaemia induction), no dose on day 5 (due to the double dose given the day before), then a normal dose for 5 days, and a triple dose on day 11 (prior to hypoglycaemia induction).