Trial reportDiabetes, obesity & metabolism2026
Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8).
Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05813912. Cited by 1 paper.
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Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
Open the trial in the graphWho cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
aimsTo investigate the efficacy and safety of intensifying once-weekly insulin icodec (icodec) with once-weekly semaglutide in adults with type 2 diabetes (T2D). MATERIALS AND
methodsONWARDS 8 was a single-arm, open-label, treat-to-target, Phase 3b trial comprising a 26-week icodec run-in period and a 26-week semaglutide intensification period. Eligible participants were adults with T2D (glycated haemoglobin [HbA1c]: 7.5%-10.5%) receiving daily basal insulin but not receiving a glucagon-like peptide-1 receptor agonist. Following the run-in period, participants with HbA1c levels > 7.0% and ≤ 10.5% were eligible for treatment intensification with semaglutide up to 1.0 mg. The primary endpoint was change in HbA1c from Week 26 (baseline) to Week 52.
resultsOverall, 148 participants were enrolled; 94 initiated semaglutide. From baseline to Week 52, mean HbA1c decreased from 7.88% (observed) to 6.66% (estimated), with an estimated mean change of -1.23%-points (95% confidence interval: -1.39, -1.07%-points; p < 0.0001). Statistically significant changes from baseline to Week 52 were observed in 7-point self-measured blood glucose profile (-1.72 mmol/L), postprandial glucose increment (-1.31 mmol/L) and body weight (-3.85 kg) (all p < 0.0001). The relative decrease in mean weekly icodec dose from Week 25 to Week 52 was 24% (69.1% of participants had their icodec dose reduced by 20% at Week 26, per protocol). From baseline to Week 57 (end of trial), the rate of combined clinically significant or severe hypoglycaemia was 0.24 episodes per person-year of exposure.
conclusionsIntensification of icodec with semaglutide was feasible, with low rates of clinically significant or severe hypoglycaemia.
trial registrationNCT05813912.
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