Investigational once-weekly basal insulin found effective, safe

  • Rosenstock J & al.
  • N Engl J Med
  • 22 Sep 2020

  • curated by Miriam Tucker
  • Clinical Essentials
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Takeaway

  • Insulin icodec, a once-weekly basal insulin analogue, has glucose-lowering and safety profiles similar to once-daily glargine.

Why this matters

  • A once-weekly formulation could improve patient adherence.

Study design

  • Randomized, double-blind, double-dummy, 26-week phase 2 trial of once-weekly icodec vs daily glargine U100 in 247 insulin-naive patients with type 2 diabetes who had HbA1c 7.0%-9.5% while taking metformin +/− a dipeptidyl peptidase 4 inhibitor.
  • Funding: Novo Nordisk.

Key results

  • Mean HbA1c dropped from:
    • 8.09% to 6.69% with icodec and
    • 7.96% to 6.87% with glargine. 
    • −1.33 vs −1.15 percentage points (P=.08).
  • Estimated percentages of patients reaching HbA1c
  • 72% with icodec vs 68% with glargine.
  • Estimated OR: 1.20 (95% CI, 0.98-2.13).
  • There were no treatment-related serious adverse events.
  • Observed incidences of combined level 2 (
  • 16.0% with icodec. 
  • 9.8% with glargine. 
  • Event rates per patient year of exposure:
    • 0.53 with icodec.
    • 0.46 with glargine. 
    • Estimated rate ratio: 1.09 (95% CI, 0.45-2.65).
  • Limitations

    • Not powered to detect significant differences between treatments for any endpoint.
    • Insulin adjustments not tailored for each treatment.
    • Patients using sulfonylureas were excluded.