Visual 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<70 mg/dL and TBR<54 mg/dL remained below the recommended targets (<4% and <1). At weeks 15 and 16, proportion of patients achieving >70% TIR and TBR<70 mg/dL <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<70 mg/dL <4% with icodec vs. IGlar U100 at weeks 15 and 16. *Proposed INN.
I. Lingvay: Advisory Panel; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Consultant; Self; TARGET PharmaSolutions, Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Zealand Pharma A/S, Research Support; Self; Mylan N. V., Sanofi. R. Beck bang: Employee; Self; Novo Nordisk A/S. M. M. Koefoed: Employee; Self; Novo Nordisk. J. K. Mader: Advisory Panel; Self; Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Roche Diabetes Care, Speaker’s Bureau; Self; Abbott Diabetes, Novo Nordisk A/S, Roche Diabetes Care, Sanofi, Stock/Shareholder; Self; decide Clinical Software GmbH. J. Pettus: Advisory Panel; Self; Novo Nordisk, Sanofi, Consultant; Self; Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, MannKind Corporation, Tandem Diabetes Care. L. Wagner: None. C. Mathieu: Advisory Panel; Self; Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Insulet and Zealand Pharma, Research Support; Self; Medtronic, Novo Nordisk, Sanofi and ActoBio Therapeutics, Speaker’s Bureau; Self; Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca and Novartis.
