open access publication

Article, 2024

Continuous Glucose Monitoring– Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-standing Type2 Diabetes Switched From a Daily Basal InsulintoOnce-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4

Diabetes Care, ISSN 0149-5992, 1935-5548, Volume 47, 4, Pages 729-738, 10.2337/dc23-2136

Contributors

Bajaj H.S. 0000-0002-1461-1465 (Corresponding author) [1] Asbjornsdottir B. 0000-0002-0178-3663 [2] Carstensen L. 0000-0002-2425-633X [2] Laugesen C. 0000-0001-9253-9457 [2] Mathieu C. 0000-0002-6099-2406 [3] Philis-Tsimikas A. 0000-0002-3986-9630 [4] Battelino T. 0000-0002-0273-4732 [5] [6]

Affiliations

  1. [1] LMC Diabetes and Endocrinology
  2. [NORA names: Canada; America, North; OECD];
  3. [2] Novo Nordisk A/S
  4. [NORA names: Novo Nordisk; Private Research; Denmark; Europe, EU; Nordic; OECD];
  5. [3] KU Leuven
  6. [NORA names: Belgium; Europe, EU; OECD];
  7. [4] Scripps Whittier Diabetes Institute
  8. [NORA names: United States; America, North; OECD];
  9. [5] University Medical Centre Ljubljana
  10. [NORA names: Slovenia; Europe, EU; OECD];

Abstract

OBJECTIVE This post hoc analysis assessed continuous glucose monitoring (CGM)–based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS Time in range (TIR) (3.9–10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), andtimebelowrange(TBR)(<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0–4], end of treatment [weeks 22–26], and follow-up [weeks 27–31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the endof-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets.

Funders

  • Novo Nordisk

Data Provider: Elsevier