Trial reportDiabetes, obesity & metabolism2017

Metformin in adults with type 1 diabetes: Design and methods of REducing with MetfOrmin Vascular Adverse Lesions (REMOVAL): An international multicentre trial.

John R Petrie, Nish Chaturvedi, Ian Ford, Irene Hramiak, Alun D Hughes, Alicia J Jenkins, Barbara E Klein, Ron Klein, Teik Chye Ooi, Peter Rossing and 4 more

Open access · hybridFull text readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. Cited by 22 papers, 4 of them syntheses that pooled it.

1number the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
3.7field-weighted citation impact, top 6% 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.

Read, but not usablea number the graph found but could not read as for or against

Progression of averaged mean far wall common carotid intima-media thickness (cIMT)metformin vs placebono interval or p-value · ascvd, obesityfeeds one cell of the map
Δ 0.02
This design provides 90% power to detect a mean difference of 0.0167 mm in cIMT progression between treatment arms (α = 0.05), assuming that up to 20% withdraw or discontinue treatment.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Metformin×cardiac & vascular function

No readable resultOpen on the map →What to test next →

4 readable studies in this cell: 1 favour the treatment, 3 find no difference, 0 favour the comparator.

Belief with this paper
0.24contested · 1 family supports, 3 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT0335546991 enrolled · 2017
Δ 3.530.08 to 6.99
NCT0047387662 enrolled · 2007
Δ -0.38
NCT0334977521 enrolled · 2017
Δ -2.57-8.32 to 3.18

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Metformin for preventing the progression of chronic kidney disease.The Cochrane database of systematic reviews · 2024 · on this map
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6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

14 authors at 9 institutions in 6 countries.

John R PetrieInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Nish ChaturvediInstitute of Cardiovascular Science, University College London, London, UK.
Ian FordInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Irene HramiakSt Joseph's Health Care, London, Ontario, Canada.
Alun D HughesInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Alicia J JenkinsNHMRC Clinical Trials Centre, University of Sydney, Australia.
Barbara E KleinDepartment of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Ron KleinDepartment of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Teik Chye OoiOttawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Canada.
Peter RossingSteno Diabetes Center and the University of Copenhagen, Copenhagen, Denmark.
Naveed SattarInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Coen D A StehouwerDepartment of Internal Medicine and Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, Maastricht, The Netherlands.
Helen M ColhounInstitute of Genetics and Molecular Medicine, University of Edinburgh, UK.
REMOVAL Trial Team
University of Glasgow · GBWisconsin Division of Public Health · USMaastricht University Medical Centre · NLMRC Institute of Genetics and Molecular Medicine · GBNational Health and Medical Research Council · AUOttawa Hospital Research InstituteSt Joseph's Health Care · CAUniversity College London · GBUniversity of Copenhagen · DK

Funding

British Heart Foundation CS/13/1/30327
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aimsCardiovascular (CV) disease is a major cause of reduced life expectancy in type 1 diabetes (T1D). Intensive insulin therapy prevents CV complications but is constrained by hypoglycaemia and weight gain. Adjunct metformin reduces insulin dose requirement and stabilizes weight but there are no data on its cardiovascular effects. We have therefore initiated an international double-blind, randomized, placebo-controlled trial (REMOVAL: REducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes) to examine whether metformin reduces progression of atherosclerosis in adults with T1D. Individuals ≥40 years of age with T1D for ≥5 years are eligible if they have ≥3 of 10 specified CV risk factors. The enrolment target is 500 participants in 17 international centres. MATERIALS AND

methodsAfter 12 weeks of single-blind placebo-controlled run-in, participants with ≥ 70% adherence are randomized to metformin or matching placebo for 3 years with insulin titrated towards HbA1c 7.0% (53 mmol/mol). The primary endpoint is progression of averaged mean far wall common carotid intima-media thickness (cIMT) measured by ultrasonography at baseline, 12, 24 and 36 months. This design provides 90% power to detect a mean difference of 0.0167 mm in cIMT progression between treatment arms (α = 0.05), assuming that up to 20% withdraw or discontinue treatment. Other endpoints include HbA1c, weight, LDL cholesterol, insulin requirement, progression of retinopathy, endothelial function and frequency of hypoglycaemia.

conclusionREMOVAL is the largest clinical trial of adjunct metformin therapy in T1D to date and will provide clinically meaningful information on its potential to impact CV disease and other complications.

Indexed as

AdultAtherosclerosisBlood GlucoseBody WeightCarotid Intima-Media ThicknessCholesterol, LDLClinical ProtocolsDiabetes Mellitus, Type 1Disease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsBlood GlucoseCholesterol, LDLGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinMetforminadjunct therapycardiovascularcarotid intima media thicknessclinical trialcomplicationsendothelial functionhypoglycaemia metformintype 1 diabetesweight

Identifiers

PMID27935183
PMCPMC5357575
OpenAlexW2563196695

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

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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.