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Once-weekly insulin icodec better than once-daily insulin glargine for patients with type 2 diabetes: ONWARDS 4 trial
![Once-weekly insulin icodec better than once-daily insulin glargine for patients with type 2 diabetes: ONWARDS 4 trial Once-weekly insulin icodec better than once-daily insulin glargine for patients with type 2 diabetes: ONWARDS 4 trial](https://medicaldialogues.in/h-upload/2023/05/10/750x450_209234-insulin.webp)
Belgium: Once-weekly insulin icodec performed equally well as once-daily insulin glargine U100 for glycemic control, required fewer basal insulin injections, and a lower bolus insulin dose with no increase in hypoglycaemic rates in type 2 diabetes patients, according to ONWARDS 4 trial. The trial findings were published in The Lancet on May 05, 2023.
Insulin icodec (icodec) is a basal insulin analogue appropriate for once-weekly dosing. Prof Chantal Mathieu, Catholic University of Leuven, Leuven, Belgium, and colleagues aimed to evaluate the safety and efficacy of once-weekly icodec versus once-daily insulin glargine U100 (glargine U100) in patients with long-standing type 2 diabetes on a basal-bolus regimen in the ONWARDS 4 trial. ONWARDS 4 is a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial.
The trial, conducted for 26 weeks, involved adults from 80 sites across nine countries (the USA, Russia, Romania, the Netherlands, Mexico, Japan, Italy, India, and Belgium). Five hundred eighty-two participants were randomly assigned in a ratio of 1:1 to receive once-weekly icodec (n=291) or glargine U100 (n=291) combined with 2–4 daily bolus insulin aspart injections.
Safety outcomes were assessed in the safety analysis set that comprised all participants randomly allocated to receive at least one dose of the trial product. The study's primary outcome was a change in HbA1c from baseline to week 26 (non-inferiority margin of 0·3 percentage points), evaluated in the complete analysis set, i.e. all randomly assigned participants. The mean duration of the participants with type 2 diabetes of 17·1 year.
The study revealed the following findings:
- At week 26, the estimated mean change in HbA1c was −1·16 percentage points in the icodec group (baseline 8·29%) and −1·18 percentage points in the glargine U100 group (baseline 8·31%), showing non-inferiority for icodec versus glargine U100 (estimated treatment difference 0·02 percentage points).
- 59% of participants in the icodec group and 57% in the glargine U100 group had an adverse event.
- Thirty-five serious adverse events were reported in 8% of participants in the icodec group, and 33 serious adverse events were reported in 9% of participants receiving glargine U100.
- Combined level 2 and level 3 hypoglycaemia rates were similar between treatment groups. No new safety concerns were identified for icodec.
Key strengths of this trial were:
- The use of masked continuous glucose monitoring.
- The inclusion of a large, diverse, and multinational population.
- The high trial completion rate.
Limitations include the open-label design and relatively short trial duration.
Reference:
Mathieu C, Ásbjörnsdóttir B, Bajaj HS, Lane W, Matos ALSA, Murthy S, Stachlewska K, Rosenstock J. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023 May 5:S0140-6736(23)00520-2. doi: 10.1016/S0140-6736(23)00520-2. Epub ahead of print. PMID: 37156252.
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751