Evidence map›Paper›PMID 39699848›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2025

AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes.

Liana K Billings, Marisse Asong, Martin Bøg, Simon Clancy, Christian Kruse, Elisabeth de Laguiche, Ernesto Maddaloni

Registry-linked trialAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04760626 (Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting), which is not on this map. 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.

NCT04760626 phase3completednot on this map

Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2022Enrolled1,085ConditionsDiabetes Mellitus, Type 2ArmsInsulin icodec, Insulin Glargine 100U/mL, Insulin Degludec, Insulin Glargine 300U/mL
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

7 authors.

Liana K BillingsDepartment of Medicine, Endeavor Health (Formerly NorthShore University HealthSystem), and University of Chicago Pritzker School of Medicine, 9977 Woods Drive, Suite 300, Skokie, IL, 60077, USA. lbillings@northshore.org.
Marisse AsongNovo Nordisk A/S, Søborg, Denmark.
Martin BøgNovo Nordisk A/S, Søborg, Denmark.
Simon ClancyNovo Nordisk A/S, Søborg, Denmark.
Christian KruseNovo Nordisk A/S, Søborg, Denmark.
Elisabeth de LaguicheNovo Nordisk A/S, Søborg, Denmark.
Ernesto MaddaloniDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).

methodsONWARDS 5 data were augmented with RWD collected from the US Ambulatory Electronic Medical Records database. Randomized and augmented comparisons (propensity-score-matched) between icodec with app and glargine U300 were weighted to provide a fully augmented estimate of the primary outcome (change in glycated hemoglobin [HbA

resultsThe nonaugmented randomized estimated treatment difference (ETD; 95% CI) between icodec with app and glargine U300 (trial stratum) for change in HbA

conclusionsUsing augmented data, the precision of the change in HbA TRIAL REGISTRATION NUMBER: The ONWARDS 5 trial is registered with ClinicalTrials.gov (NCT04760626).

Indexed as

Augmented dataClinical trialInsulinPropensity score matchingType 2 diabetes

Identifiers

PMID39699848
PMCPMC11794749

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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 OpenQuestion graph.