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Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial.

Lancet (London, England)2025-06-26PubMed
Total: 87.0Innovation: 8Impact: 0Rigor: 0Citation: 0

Summary

In adults with type 2 diabetes already using basal–bolus therapy, once-weekly efsitora was non-inferior to daily glargine U100 for HbA1c control over 26 weeks in a phase 3 treat-to-target trial. The weekly regimen offers reduced injection burden without compromising efficacy.

Key Findings

  • Once-weekly efsitora was non-inferior to daily glargine U100 for HbA1c change at 26 weeks.
  • Trial included adults on basal–bolus regimens across multiple countries and sites.
  • Weekly dosing offers potential adherence and satisfaction benefits in high-burden regimens.

Clinical Implications

Weekly basal insulin may be considered in basal–bolus users to reduce burden; clinicians should monitor for glycemic targets and individualize prandial dosing alongside the weekly basal strategy.

Why It Matters

Extends weekly basal insulin evidence to the complex basal–bolus population, addressing a high-burden regimen where reducing injection frequency could meaningfully improve adherence.

Limitations

  • Open-label design with potential bias
  • 26-week duration limits longer-term safety and durability assessments

Future Directions

Assess long-term durability, hypoglycemia patterns, patient-reported outcomes, and economic impact of weekly basal insulin in basal–bolus users.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Phase 3 randomized controlled non-inferiority trial
Study Design
OTHER