Evidence map›Paper›PMID 19501900›Full record

Trial reportLancet (London, England)2009

Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial.

Philip D Home, Stuart J Pocock, Henning Beck-Nielsen, Paula S Curtis, Ramon Gomis, Markolf Hanefeld, Nigel P Jones, Michel Komajda, John J V McMurray, RECORD Study Team

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00379769. Cited by 461 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
461citing papers in PubMed, 21 pooled it
87.1field-weighted citation impact, top 1% 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.

NCT00379769 phase3completed

A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia

Ran2001Enrolled4,447Registered outcomes53Posted comparisons10ConditionsDiabetes Mellitus, Type 2ArmsMetformin, Rosiglitazone, Sulfonylurea
PMID 18435852PMID 16025252PMID 17551159PMID 17517066other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

461 citing papers in PubMed, 21 syntheses or guidelines pooled it, 1,392 citations in OpenAlex.

  1. Pooled it
  2. Thiazolidinediones for people with chronic kidney disease and diabetes.The Cochrane database of systematic reviews · 2025
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  7. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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  12. Addressing Regional Differences in Diabetes Progression: Global Calibration for Diabetes Simulation Model.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2019
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401 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 4 countries.

Philip D HomeNewcastle Diabetes Centre and Newcastle University, Newcastle upon Tyne, UK. philip.home@newcastle.ac.uk
Stuart J Pocock
Henning Beck-Nielsen
Paula S Curtis
Ramon Gomis
Markolf Hanefeld
Nigel P Jones
Michel Komajda
John J V McMurray
RECORD Study Team
GlaxoSmithKline (United Kingdom) · GBEndokrinologikum · DELondon School of Hygiene & Tropical Medicine · GBNewcastle University · GBPitié-Salpêtrière Hospital · FRUniversitat de Barcelona · ESUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety.

methodsIn a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1.20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769.

findings321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5.5-year follow-up, meeting the criterion of non-inferiority (HR 0.99, 95% CI 0.85-1.16). HR was 0.84 (0.59-1.18) for cardiovascular death, 1.14 (0.80-1.63) for myocardial infarction, and 0.72 (0.49-1.06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2.10, 1.35-3.27, risk difference per 1000 person-years 2.6, 1.1-4.1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years.

interpretationAddition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs.

fundingGlaxoSmithKline plc, UK.

Indexed as

Administration, OralAngina, UnstableBody WeightCholesterol, HDLCholesterol, LDLDiabetes Mellitus, Type 2DiureticsDrug Therapy, CombinationDrug UtilizationFemaleFractures, BoneGlycated HemoglobinHeart FailureHospitalizationHumansHydroxymethylglutaryl-CoA Reductase InhibitorsCholesterol, HDLCholesterol, LDLDiureticsGlycated Hemoglobinhemoglobin A1c protein, humanHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsMetforminRosiglitazoneSulfonylurea CompoundsThiazolidinediones

Identifiers

PMID19501900
OpenAlexW2131490500

What Socratic holds

Texttitle and abstract
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.