Abstract 3: CGM-derived parameters for once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-Naïve patients with T2D

Abstract

Insulin icodec (icodec) is a once-weekly basal insulin in development. This post hoc analysis used data from the NCT03951805 trial to investigate CGM-derived time in, above, below range (TIR, TAR, TBR) and glycemic variability measured as coefficient of variation (CV%). Insulin-naïve patients with T2D (N=205) received insulin glargine U100 (IGlar U100; pre-breakfast SMBG target 80-130 mg/dL, adjusted ±4U/day), icodec titration A (80- 130 mg/dL, ±21U/week), B (80-130 mg/dL, ±28U/week; most relevant comparator to IGlar U100), or C (70-108 mg/dL, ±28U/week). Treatments were titrated weekly. TIR (70-180 mg/dL), TAR (>180 mg/dL), TBR (<70 and <54 mg/dL) and CV% were calculated during the 2-week screening and the 16-week treatment periods using double-blinded Dexcom G6 CGM data. During the trial, across arms, TIR increased to >70% from weeks 7 and 8, TAR decreased to <25% from weeks 11 and 12, TBR and TBR remained below the recommended targets (<4% and <1). At weeks 15 and 16, proportion of patients achieving >70% TIR and TBR <4% were 63.3% for titration A, 80.0% for B, 66.0% for C and 64.0% for IGlar U100. CV% increased slightly over time but remained <36% in all arms. TIR increased during the trial across treatments, and similar or numerically higher proportion of patients achieved >70% TIR and TBR <4% with icodecvs. IGlar U100 at weeks 15 and 16