Evidence mapPaperPMID 19245711Full record

Trial reportCardiovascular diabetology2009

Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone.

Sean D Sullivan, Rafael Alfonso-Cristancho, Chris Conner, Mette Hammer, Lawrence Blonde

6 registry-linked trialsOpen access · goldFull text readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in Cardiovascular diabetology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00294723. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT00294723 phase3terminated

Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes

Ran2006Enrolled746Registered outcomes17Posted comparisons45ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, liraglutide, Placebo
Open the trial in the graph
NCT00318422 phase3completed

Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

Ran2006Enrolled1,041Registered outcomes5Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, liraglutide, Rosiglitazone
Open the trial in the graph
NCT00318461 phase3completed

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Ran2006Enrolled1,091Registered outcomes14Posted comparisons74ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, liraglutide, Metformin, Placebo
Open the trial in the graph
NCT00331851 phase3completed

Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

Ran2006Enrolled584Registered outcomes5Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, Insulin glargine, liraglutide, Metformin
Open the trial in the graph
NCT00333151 phase3completed

Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

Ran2006Enrolled576Registered outcomes4Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Metformin, Rosiglitazone
Open the trial in the graph
NCT00518882 phase3completed

Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

Ran2007Enrolled467Registered outcomes55Posted comparisons85ConditionsDiabetes, Diabetes Mellitus, Type 2Armsexenatide, liraglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Review
  7. 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

5 authors at 4 institutions in 2 countries.

Sean D SullivanPharmaceutical, Outcomes Research and Policy Program, University of Washington, Seattle, USA. sdsull@u.washington.edu
Rafael Alfonso-Cristancho
Chris Conner
Mette Hammer
Lawrence Blonde
Seattle University · USNovo Nordisk (Denmark) · DKNovo Nordisk (United States) · USOchsner Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPoor control of type 2 diabetes results in substantial long-term consequences. Studies of new diabetes treatments are rarely designed to assess mortality, complication rates and costs. We sought to estimate the long-term consequences of liraglutide and rosiglitazone both added to glimepiride.

methodsTo estimate long-term clinical and economic consequences, we used the CORE diabetes model, a validated cohort model that uses epidemiologic data from long-term clinical trials to simulate morbidity, mortality and costs of diabetes. Clinical data were extracted from the LEAD-1 trial evaluating two doses (1.2 mg and 1.8 mg) of a once daily GLP-1 analog liraglutide, or rosiglitazone 4 mg, on a background of glimepiride in type 2 diabetes. CORE was calibrated to the LEAD-1 baseline patient characteristics. Survival, cumulative incidence of cardiovascular, ocular and renal events and healthcare costs were estimated over three periods: 10, 20 and 30 years.

resultsIn a hypothetical cohort of 5000 patients per treatment followed for 30 years, liraglutide 1.2 mg and 1.8 mg had higher survival rates compared to the group treated with rosiglitazone (15.0% and 16.0% vs. 12.6% after 30 years), and fewer cardiovascular, renal, and ocular events. Cardiovascular death rates after 30 years were 69.7%, 68.4% and 72.5%, for liraglutide 1.2 mg, 1.8 mg, and rosiglitazone, respectively. First and recurrent amputations were lower in the rosiglitazone group, probably due to a 'survival paradox' in the liraglutide arms (number of events: 565, 529, and 507, respectively). Overall cumulative costs per patient, were lower in both liraglutide groups compared to rosiglitazone (US$38,963, $39,239, and $40,401 for liraglutide 1.2 mg, 1.8 mg, and rosiglitazone, respectively), mainly driven by the costs of cardiovascular events in all groups.

conclusionUsing data from LEAD-1 and epidemiologic evidence from the CORE diabetes model, projected rates of mortality, diabetes complications and healthcare costs over the long term favor liraglutide plus glimepiride over rosiglitazone plus glimepiride.

trial registrationLEAD-1 NCT00318422; LEAD-2 NCT00318461; LEAD-3 NCT 00294723; LEAD-4 NCT00333151; LEAD-5 NCT00331851; LEAD-6 NCT00518882.

Indexed as

AgedCohort StudiesDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleFollow-Up StudiesGlucagon-Like Peptide 1HumansLiraglutideMaleMiddle AgedRosiglitazoneSulfonylurea CompoundsThiazolidinedionesTreatment OutcomeglimepirideGlucagon-Like Peptide 1LiraglutideRosiglitazoneSulfonylurea CompoundsThiazolidinediones

Identifiers

PMID19245711
PMCPMC2667489
OpenAlexW2003271782

What Socratic holds

Textfull text, public
LicenceCC BY
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.