Evidence mapPaperPMID 42387310Full record

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).

Krzysztof Strojek, Andreas Liebl, Neha Narendra Mumbaikar, Stinne Byrholdt Søgaard, Sara Kehlet Watt, Athena Philis-Tsimikas

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05813912 phase3completed

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

Ran2023Enrolled148Registered outcomes9Posted comparisons1ConditionsDiabetes Mellitus, Type 2ArmsInsulin icodec, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Krzysztof StrojekDepartment of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze, Medical University of Silesia, Zabrze, Poland.ORCID https://orcid.org/0000-0002-6260-8674
Andreas LieblDepartment of Internal Medicine, Center for Diabetes and Metabolism, m&i-Fachklinik, Bad Heilbrunn, Germany.
Neha Narendra MumbaikarNovo Nordisk Service Centre India Private Ltd, Bangalore, India.
Stinne Byrholdt SøgaardNovo Nordisk A/S, Søborg, Denmark.
Sara Kehlet WattNovo Nordisk A/S, Søborg, Denmark.
Athena Philis-TsimikasScripps Whittier Diabetes Institute, San Diego, California, USA.

Funding

Novo Nordisk A/S
6 · The paper itself

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.

Indexed as

Diabetes Mellitus, Type 2Glucagon-Like PeptidesHypoglycemic AgentsInsulinAdultAgedBlood GlucoseDrug Administration ScheduleDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaMaleMiddle AgedSemaglutideBlood GlucoseGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinSemaglutideantidiabetic drugbasal insulinclinical trialtype 2 diabetes

Identifiers

PMID42387310
PMCPMC13449048

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.