Evidence mapPaperPMID 32227613Full record

Trial reportDiabetes, obesity & metabolism2020

Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6).

Esteban Jódar, Marie Michelsen, William Polonsky, Rosangela Réa, Anna Sandberg, Tina Vilsbøll, Mark Warren, Signe Harring, Uwe Ziegler, Stephen Bain

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01720446. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
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.

NCT01720446 phase3completed

A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)

Ran2013Enrolled3,297Registered outcomes16Posted comparisons54ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
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  8. Review
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  12. Obesity and psychological distress.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2023
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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

10 authors.

Esteban JódarFaculty of Medicine, Universidad Europea de Madrid, Madrid, Spain.ORCID 0000-0002-1234-8560
Marie MichelsenNovo Nordisk A/S, Søborg, Denmark.
William PolonskyBehavioral Diabetes Institute, San Diego, California.
Rosangela RéaDepartment of Clinical Medicine, SEMPR, Universidade Federal do Paraná, Curitiba, Brazil.
Anna SandbergNovo Nordisk A/S, Søborg, Denmark.
Tina VilsbøllSteno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.ORCID 0000-0002-0456-6787
Mark WarrenDepartment of Endocrinology, Physicians East, Greenville, North Carolina.ORCID 0000-0001-6693-9860
Signe HarringNovo Nordisk A/S, Søborg, Denmark.
Uwe ZieglerNovo Nordisk A/S, Søborg, Denmark.
Stephen BainDiabetes Research Unit Cymru, Swansea University Medical School, Swansea, UK.ORCID 0000-0001-8519-4964

Funding

Novo Nordisk
6 · The paper itself

Abstract

aimTo assess what drives change in health-related quality of life (HRQoL) in type 2 diabetes in the SUSTAIN 6 trial and identify potential mediators of the treatment effect of semaglutide on HRQoL scores. MATERIALS AND

methodsThe Short Form (SF)-36v2® questionnaire [comprising physical component summary (PCS) and mental component summary (MCS)] was used to assess changes in HRQoL from baseline to week 104, by treatment, in a prespecified analysis. This post-hoc analysis assessed change in PCS and MCS using the following factors as parameter/covariate, using descriptive statistics and linear regressions: major adverse cardiac events, hypoglycaemia, gastrointestinal adverse events, at least one episode of nausea, vomiting or diarrhoea, and change in glycated haemoglobin (HbA1c), body weight, blood pressure, heart rate and estimated glomerular filtration rate.

resultsMean change in overall PCS score was +1.0 with semaglutide versus +0.4 with placebo, and +0.5 versus -0.2 for MCS. The treatment effect of semaglutide versus placebo (unadjusted estimate) was 0.7 [(95% confidence interval 0.1, 1.2); P = 0.018] on PCS and this was reduced when adjusted for change in HbA1c [0.4 (-0.2, 1.0), P = .167] and body weight [0.3 (-0.3, 0.9), P = .314]. The unadjusted treatment effect on MCS [0.7 (-0.0, 1.5), P = .054] was only reduced when adjusted for change in HbA1c [0.3 (-0.4, 1.1), P = .397]. When adjusting for all other parameters separately, the estimated effect of semaglutide on PCS and MCS qualitatively did not change.

conclusionsSemaglutide improved HRQoL versus placebo; greater improvements with semaglutide versus placebo were possibly mediated, in part, by change in HbA1c and body weight. Clinicaltrials.gov: NCT01720446 (SUSTAIN 6).

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Glucagon-Like PeptidesHeart Disease Risk FactorsHumansHypoglycemic AgentsQuality of LifeRisk FactorsSemaglutideStandard of CareTreatment OutcomeGlucagon-Like PeptidesHypoglycemic AgentsSemaglutidecardiovascular diseaseGLP-1 analoguehypoglycaemiaincretin therapytype 2 diabetesweight control

Identifiers

PMID32227613
PMCPMC7383680

What Socratic 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 Socratic graph.