Introduction and Objective: This study investigated the glucodynamics and hypoglycemia risk associated with exercise or fasting during once-weekly basal insulin icodec treatment.Methods: Thirty basal insulin-treated, physically active individuals with T2D were enrolled. Icodec was dosed for ≥7 wks to target FPG of 80-130 mg/dL. When icodec steady state was achieved, 40 min cycling (EXE; 60% VO2 peak) was performed 43 h post-dose. The following week, participants fasted for 18 h (FAST) starting 26 h post-dose. If PG<72 mg/dL between 90 min pre-EXE and 140 min post-EXE or during FAST (based on pre-scheduled sampling), oral carbohydrate (EXE) or IV glucose (FAST) was given. Blinded CGM data were collected for EXE (24 h), FAST (18 h) and corresponding reference periods (REF).Results: Baseline characteristics of the 8 females/22 males were: mean±SD age 60±10 yrs, BMI 28.7±4.2 kg/m2, HbA1c 7.4±0.8%, pre-breakfast self-measured PG 112±11 mg/dL, daily basal insulin dose 0.27±0.11 U/kg). Mean TBR54 mg/dL was 0.27% for EXE and 0.15% for FAST (Table). No clinically significant or severe hypoglycemia was reported. Oral carbohydrate was given to 1, 0 and 3 participants pre-, during and post-EXE. IV glucose was given to 15 participants during FAST. The earliest dose of IV glucose was required 10.6 h after start of FAST.Conclusion: These results strengthen the safety profile of icodec and provide guidance on its clinical use in people with T2D during exercise or fasting.
T.R. Pieber: Other – Speaker, Board member, Advisory panel; Current; Arecor. Research Support; Current; AstraZeneca. Other – Research support, Speaker, Board member, Advisory panel; Current; Eli Lilly and Company, Novo Nordisk, Sanofi. Employee; Current; CBmed – Center for Biomarker Research in Medicine. H.S. Bajaj: Research Support; Current; Abbott Diagnostics, Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Ionis Pharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Roche Pharmaceuticals, Vertex Pharmaceuticals Incorporated, Arrowhead Pharmaceuticals, Inc. G. Fluhr: None. K.R. Klein: Consultant; Current; Roche Pharmaceuticals, Novo Nordisk A/S. Advisory Panel; Current; vTv Therapeutics. Consultant; Current; Antag Therapeutics, Metsera. T.M. Pagliaro Rocha: None. H. Sourij: Advisory Panel; Current; Novo Nordisk A/S, Amarin Corporation, Amgen Inc., Eli Lilly and Company, Bayer AG, Boehringer Ingelheim International GmbH. Speaker’s Bureau; Current; AstraZeneca. Advisory Panel; Current; Novartis AG. Speaker’s Bureau; Current; Amarin Corporation, Amgen Inc., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Daiichi Sankyo, Sanofi. E. Svehlikova: None. K. Udupa: None. S.K. Watt: Employee; Current; Novo Nordisk. M. Willerslev-Olsen: Employee; Current; Novo Nordisk. R. Ribel-Madsen: Employee; Current; Novo Nordisk A/S. Stock/Shareholder; Current; Novo Nordisk A/S.
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