Once-weekly insulin icodec as novel treatment for type 2 diabetes mellitus: A systematic review and meta-analysis of randomized clinical trials

Abstract

Aims: The primary objective of this investigation is to examine the efficacy and safety of insulin icodec when compared to regular basal insulin for the management of type 2 diabetes mellitus (T2DM).

Methods: A comprehensive search was conducted on the Cochrane Library, Scopus, ClinicalTrials.gov, and Medline databases up until August 19th, 2023. This review incorporates literature that examines the comparison between insulin icodec and basal insulin. The risk of bias was assessed by using RoB v2 tool from Cochrane Collaborations. We employed random-effect models to analyze the mean difference (MD) and odds ratio (OR) for presentation of the outcomes.

Results: A total of nine trials with 3,963 participants were incorporated. Five included trials had "low-risk" of bias, whereas the remaining four trials had "some-concern" risk of bias due to protocol deviations from intended intervention. The results of our meta-analysis showed no significant difference in the reduction of HbA1c levels between insulin icodec and regular basal insulin (MD -0.11 %; 95 %CI: -0.23, 0.01, p = 0.08, I² = 91 %). The fasting plasma glucose (FPG) and body weight change from baseline also did not differ significantly between two groups. Meanwhile, the total adverse events (TAEs) were shown to be higher in the insulin icodec; however, the serious AEs (SAEs) and clinically significant hypoglycemia did not differ significantly between insulin icodec and these active controls.

Conclusions: This study suggests similar efficacy and safety between insulin icodec and regular basal insulin. Further clinical trials are still needed to confirm the results of our study.

Registration details: CRD42023453635.

Keywords: Antidiabetic; Diabetes; Endocrinology; Insulin; Treatment.