Introduction & Objective: ONWARDS 6 assessed the efficacy and safety of once-weekly insulin icodec (icodec) vs once-daily insulin degludec (degludec) in adults with type 1 diabetes (T1D). This post hoc analysis evaluated the impact of glycemic variability on efficacy and safety outcomes.
Methods: Outcomes were assessed across coefficient of variation (CV) subgroups (≤36% and >36%) based on CGM data from week 0-2.
Results: Estimated change in A1C with icodec vs degludec from baseline to week 26 was similar regardless of CV subgroup. In both arms, a numerically higher proportion of people with CV ≤36% vs CV >36% achieved A1C <7.0% at week 26. Estimated rate ratios (icodec/degludec) of combined clinically significant or severe hypoglycemia and CGM-based clinically significant hypoglycemic episodes were similar regardless of CV subgroup (Table). In both arms, hypoglycemia rates were numerically lower for people with CV ≤36% vs CV >36%. Time below range (<70 mg/dL and <54 mg/dL) during weeks 22-26 in the CV ≤36% subgroup was below recommended targets (<4% and <1%, respectively) and comparable between arms.
Conclusion: Similar to degludec, when used as part of a basal-bolus regimen in T1D, once-weekly icodec may offer a lower risk of hypoglycemia for people with low glycemic variability (CV ≤36%) than for those with high glycemic variability (CV >36%).
C. Irace: Board Member; Abbott, Roche Diabetes Care, Novo Nordisk, Medtronic. K. Begtrup: Employee; Novo Nordisk A/S. M. Fragão Marques: None. S.K. Watt: Employee; Novo Nordisk. D.C. Klonoff: Consultant; Afon Technology Ltd, Better Therapeutics, Inc, Glucotrack, LIfecare, Nevro Corp., Novo Nordisk, Samsung, Thirdwayv Inc.
Novo Nordisk A/S