Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1
Authors' conclusion
These CGM data support the long-term efficacy and safety of icodec versus glargine U100 during treatment and indicated no increase in the duration of individual hypoglycaemic episodes with icodec versus glargine U100 in insulin-naive individuals with type 2 diabetes.
Study context
- Population
- Insulin-naive adults (≥18 years) with T2D (HbA1c 7.0–11.0%)full analysis set
- Participants
- 492 vs 492
- Comparison
- Once-weekly insulin icodec vs once-daily insulin glargine U100
- Icodecn = 492
- Glargine U100n = 492reference
Methodological detailsexploratory analysis, open-label, treat-to-target, phase 3a, 143 sites, 12 countries, double-masked continuous glucose monitoring (CGM)
- Exploratory analysis
- Open-label
- Treat-to-target
- Phase 3a
- 143 sites, 12 countries
- Double-masked CGM
Primary result
As reported in the abstract
CGM-based metrics (TIR, TITR, TAR, TBR) and hypoglycaemic episode duration
- Treatment initiation (weeks 0-4): no statistically significant differences in mean % TIR, time in tight range (TITR), time above range (TAR) and time below range (TBR), icodec vs glargine U100
- Midtrial, end of main phase and end of extension phase: mean % TIR and TITR significantly greater and mean % TAR significantly lower with icodec vs glargine U100
- Mean % TIR met CGM target (>70%) with icodec but not with glargine U100 during these three periods
- Follow-up: mean % TIR, TITR, TAR and TBR did not significantly differ
- Exploratory analysis
Safety
TBR (<3.9 mmol/L and <3.0 mmol/L) · all study periods
- TBR low and below recommended targets (<4% and <1%) in both groups; no significant difference for <3.0 mmol/L threshold
Duration of hypoglycaemic episodes (sensor glucose <3.9 mmol/L ≥15 min) · throughout the trial
- Duration of overall hypoglycaemic episodes similar between groups (median duration ≤35 min)
Original publication
Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1. Lancet Diabetes Endocrinol. Published 4 October 2024. doi:10.
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