Type 2 & other diabetes

Pharmacokinetic/Pharmacodynamic Modeling of Efficacy and Hypoglycemia Rate When Switching From Once-Daily Basal Insulin to Once-Weekly Insulin Icodec Without or With a One-Time Additional Dose in Insulin-Experienced Individuals With Type 2 Diabetes

Endocr PractPublished Pharmacokinetic/pharmacodynamic modelling analysis of the ONWARDS 2 and 4 randomised trials

Authors' conclusion

This PK/PD model analysis suggests that omitting administration of a 50% one-time additional dose when switching to icodec from daily basal insulin would not be predicted to result in any sustained effects.

Study context

Population
Insulin-experienced individuals with T2D on a basal (ONWARDS 2) or basal-bolus (ONWARDS 4) insulin regimen2 RCTs
Comparison
Switching from daily basal insulin to icodec without vs with a 50% one-time additional dose (first injection only)
Methodological detailsmodel development and validation, phase 3a trial data
  • Model development and validation
  • Phase 3a trial data

Primary result

As reported in the abstract

Model-predicted prebreakfast SMBG · week 26
  • Mild, transient (1-2 weeks) increase in prebreakfast SMBG after initiation without vs with additional dose, decreasing to matching levels by week 4 and similar until end of treatment (week 26)

Further findings

No model-predicted differences between groups in HbA1c reduction or clinically significant hypoglycaemia over 26 weeks, or in weekly icodec dose at week 26

Original publication

Pharmacokinetic/Pharmacodynamic Modeling of Efficacy and Hypoglycemia Rate When Switching From Once-Daily Basal Insulin to Once-Weekly Insulin Icodec Without or With a One-Time Additional Dose in Insulin-Experienced Individuals With Type 2 Diabetes. Endocr Pract. Published 2 December 2024. doi:10.1016/j.eprac.2024.11.009

Composed by AI from the published abstract and checked against it. How Briefs are made →

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