Evidence map›Paper›PMID 35546450›Full record

Trial reportDiabetes, obesity & metabolism2022

Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial.

Monika Kellerer, Margit Staum Kaltoft, Jack Lawson, Lasse Lykke Nielsen, Krzysztof Strojek, Ömür Tabak, Stephan Jacob

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03689374. Cited by 40 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 10 pooled it
8.2field-weighted citation impact, top 2% of its field
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.

NCT03689374 phase3completed

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

Ran2018Enrolled2,274Registered outcomes25Posted comparisons1ConditionsDiabetes Mellitus, Type 2ArmsInsulin Aspart, Insulin glargine U100, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 10 syntheses or guidelines pooled it, 68 citations in OpenAlex.

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  18. Dose-Response and Clinical Equivalence of Semaglutide and Tirzepatide for Weight Loss in Type 2 Diabetes: A Model-Based Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
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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 at 5 institutions in 4 countries.

Monika KellererCentre for Internal Medicine I, Marienhospital, Stuttgart, Germany.ORCID 0000-0002-9834-5976
Margit Staum KaltoftNovo Nordisk A/S, Søborg, Denmark.
Jack LawsonNovo Nordisk A/S, Søborg, Denmark.
Lasse Lykke NielsenNovo Nordisk A/S, Søborg, Denmark.
Krzysztof StrojekDepartment of Internal Diseases Diabetology and Cardiometabolic Diseases, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.
Ömür TabakIstanbul Kanuni Sultan Suleyman Education and Research Hospital, Istanbul, Turkey.
Stephan JacobDepartment of Internal Medicine, Division of Endocrinology/Diabetology, Cardiometabolic Institute, Villingen-Schwenningen, Germany.ORCID 0000-0002-4954-1145
Novo Nordisk (Denmark) · DKİstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi · TRMarienhospital Stuttgart · DEMedical University of Silesia · PLNephrologisches Zentrum Villingen-Schwenningen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare the efficacy and safety of once-weekly (OW) semaglutide versus thrice-daily (TID) insulin aspart (IAsp) in participants with inadequately controlled type 2 diabetes (T2D) treated with insulin glargine (IGlar) and metformin. MATERIALS AND

methodsSUSTAIN 11 (NCT03689374) was a randomized (1:1), parallel, open-label, multinational, phase 3b trial. After a 12-week run-in to optimize once-daily IGlar U100, 1748 adults with T2D (HbA1c >7.5% to ≤10.0%) were randomized to OW semaglutide or TID IAsp as add-on to optimized IGlar and metformin for 52 weeks. The primary outcome was change in HbA1c from randomization to week 52. Confirmatory secondary endpoints included the occurrence of severe hypoglycaemic episodes and change in body weight (BW). Safety was assessed.

resultsHbA1c (randomization: 8.6% [70.0 mmol/mol]) decreased by 1.5% points (16.6 mmol/mol) and 1.2% points (13.4 mmol/mol) with semaglutide (n = 874) and IAsp (n = 874), respectively (estimated treatment difference [ETD] -0.29% points [95% confidence interval {CI} -0.38; -0.20]; P < .0001 for non-inferiority). Few severe hypoglycaemic episodes were recorded in either group, with no statistically significant difference between the groups. Change in BW from randomization (87.9 kg) to week 52 was in favour of semaglutide (-4.1 kg) versus IAsp (+2.8 kg) (ETD -6.99 kg [95% CI -7.41; -6.57]). A higher proportion of participants experienced adverse events with semaglutide (58.5%) versus IAsp (52.1%); most were mild to moderate.

conclusionsIn this basal insulin-treated population, OW semaglutide improved glycaemic control to a greater extent than TID IAsp and provided numerically greater weight loss.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaMetforminAdultBlood GlucoseBody WeightDrug Therapy, CombinationGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemic AgentsInsulin AspartInsulin GlargineSemaglutideTreatment OutcomeBlood GlucoseGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsInsulin AspartInsulin GlargineMetforminSemaglutideGLP-1 analogueglycaemic controlhypoglycaemiainsulin therapytype 2 diabetesweight control

Identifiers

PMID35546450
PMCPMC9545869
OpenAlexW4280597148

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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 OpenQuestion graph.