Trial reportLancet (London, England)2009

Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.

Alan Garber, Robert Henry, Robert Ratner, Pedro A Garcia-Hernandez, Hiromi Rodriguez-Pattzi, Israel Olvera-Alvarez, Paula M Hale, Milan Zdravkovic, Bruce Bode, LEAD-3 (Mono) Study Group

5 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2009. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it . It reports registered trial NCT00294723. Cited by 376 papers, 17 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
376citing papers in PubMed, 17 pooled it
64.3field-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.

← favours the treatmentfavours the comparator →
-0.830 · no effect
Change in proportion of glycosylated haemoglobin (HbA(1c))liraglutide 1.2 mg vs glimepiride 8 mgfavours the treatment · hypertension, t2dfeeds one cell of the map
Δ -0.33-0.53 to -0.13p=0.0014
FINDINGS: At 52 weeks, HbA(1c) decreased by 0.51% (SD 1.20%) with glimepiride, compared with 0.84% (1.23%) with liraglutide 1.2 mg (difference -0.33%; 95% CI -0.53 to -0.13, p=0.0014) and 1.14% (1.24%) with liraglutide 1.8 mg (-0.62; -0.83 to -0.42, p<0.0001).
Change in proportion of glycosylated haemoglobin (HbA(1c))liraglutide 1.8 mg vs glimepiride 8 mgfavours the treatment · hypertension, t2dfeeds one cell of the map
Δ -0.62-0.83 to -0.42
FINDINGS: At 52 weeks, HbA(1c) decreased by 0.51% (SD 1.20%) with glimepiride, compared with 0.84% (1.23%) with liraglutide 1.2 mg (difference -0.33%; 95% CI -0.53 to -0.13, p=0.0014) and 1.14% (1.24%) with liraglutide 1.8 mg (-0.62; -0.83 to -0.42, p<0.0001).

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.

GLP-1 receptor agonists×glycemic control

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

40 readable studies in this cell: 96 favour the treatment, 17 find no difference, 10 favour the comparator.

Belief with this paper
0.91replicated · 68 families support, 7 contradict · against placebo
Without it
0.91This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper’s trial, registry resultNCT00294723 · 746 enrolled · 2006
Δ -0.62-0.83 to -0.42
This paper · 2009
Δ -0.33-0.53 to -0.13
NCT017204463,297 enrolled · 2013
Δ -0.66-0.80 to -0.52
NCT036893742,274 enrolled · 2018
Δ -0.29-0.38 to -0.20
NCT039879191,879 enrolled · 2019
Δ -0.51-0.64 to -0.38
NCT026078651,864 enrolled · 2016
Δ -0.50-0.60 to -0.40
NCT013360231,663 enrolled · 2011
Treatment contrast -0.64-0.75 to -0.53
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT018365231,398 enrolled · 2013
Δ -0.20-0.32 to -0.07
NCT019301881,231 enrolled · 2013
Δ -1.06-1.21 to -0.91
NCT007344741,202 enrolled · 2008
Δ -0.71-0.87 to -0.55
NCT020581471,170 enrolled · 2014
Δ -0.29-0.38 to -0.19
NCT003184611,091 enrolled · 2006
Δ -1.09-1.30 to -0.88
NCT021289321,089 enrolled · 2014
Δ -0.81-0.96 to -0.67
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.

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
NCT01761318 phase4completedstarted 2013, after this paper: background citation

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Ran2013Enrolled50Registered outcomes48Posted comparisons0ConditionsCardiovascular Disease, Diabetes Mellitus Type 2, Diastolic Dysfunction, Fatty LiverArmsliraglutide, Liraglutide - Placebo
Open the trial in the graph
NCT02001363 naunknown statusstarted 2013, after this paper: background citation

Protective Effect of Glucagonlike Peptide-1 on Reperfusion Injury in Patients With Acute Myocardial Infarction

Ran2013Enrolled90Registered outcomes5Posted comparisons0ConditionsAcute Myocardial InfarctionArmsliraglutide (Novo Nordisk, Bagsværd, Denmark), liraglutide placebo (Novo Nordisk)
PMID 19151200PMID 19136619PMID 21920963other papers from this trial
Open the trial in the graph
NCT02930265 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Chinese People's Liberation Army General Hospital

TypeinterventionalSponsorChinese PLA General HospitalRan2016 to 2018Enrolled400ConditionsIschemic CardiomyopathyArmsLiraglutide
NCT04272359 unknown statusnot on this mapstarted 2019, after this paper: background citation

Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus

Typeobservational_patient_registrySponsorUniversity of MilanRan2019 to 2021Enrolled138ConditionsT2DM (Type 2 Diabetes Mellitus), Diet, Healthy, Renal Function Disorder, AlbuminuriaArmsSulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas
5 · Its place in the literature

Who cites it

376 citing papers in PubMed, 17 syntheses or guidelines pooled it, 1,049 citations in OpenAlex.

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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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  18. Trial
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316 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

10 authors at 7 institutions in 3 countries.

Alan GarberBaylor College of Medicine, Houston, TX, USA.
Robert Henry
Robert Ratner
Pedro A Garcia-Hernandez
Hiromi Rodriguez-Pattzi
Israel Olvera-Alvarez
Paula M Hale
Milan Zdravkovic
Bruce Bode
LEAD-3 (Mono) Study Group
Atlanta Diabetes Associates · USBaylor College of Medicine · USGeorgetown University · USHospital Universitario Dr José Eleuterio Gonzalez · MXNovo Nordisk (Denmark) · DKNovo Nordisk (United States) · USUniversity of San Diego · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

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

backgroundNew treatments for type 2 diabetes mellitus are needed to retain insulin-glucose coupling and lower the risk of weight gain and hypoglycaemia. We aimed to investigate the safety and efficacy of liraglutide as monotherapy for this disorder.

methodsIn a double-blind, double-dummy, active-control, parallel-group study, 746 patients with early type 2 diabetes were randomly assigned to once daily liraglutide (1.2 mg [n=251] or 1.8 mg [n=247]) or glimepiride 8 mg (n=248) for 52 weeks. The primary outcome was change in proportion of glycosylated haemoglobin (HbA(1c)). Analysis was done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NTC00294723.

findingsAt 52 weeks, HbA(1c) decreased by 0.51% (SD 1.20%) with glimepiride, compared with 0.84% (1.23%) with liraglutide 1.2 mg (difference -0.33%; 95% CI -0.53 to -0.13, p=0.0014) and 1.14% (1.24%) with liraglutide 1.8 mg (-0.62; -0.83 to -0.42, p<0.0001). Five patients in the liraglutide 1.2 mg, and one in 1.8 mg groups discontinued treatment because of vomiting, whereas none in the glimepiride group did so.

interpretationLiraglutide is safe and effective as initial pharmacological therapy for type 2 diabetes mellitus and leads to greater reductions in HbA(1c), weight, hypoglycaemia, and blood pressure than does glimepiride.

Indexed as

Blood GlucoseBlood PressureDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucagon-Like Peptide 1Glycated HemoglobinHumansHypoglycemic AgentsLiraglutideMaleMiddle AgedSulfonylurea CompoundsBlood GlucoseglimepirideGlucagon-Like Peptide 1Glycated HemoglobinHypoglycemic AgentsLiraglutideSulfonylurea Compounds

Identifiers

PMID18819705
OpenAlexW2098459806

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.