Evidence map›Paper›PMID 19317822›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2009

Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU).

M Marre, J Shaw, M Brändle, W M W Bebakar, N A Kamaruddin, J Strand, M Zdravkovic, T D Le Thi, S Colagiuri, LEAD-1 SU study group

3 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00318422. Cited by 290 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
290citing papers in PubMed, 18 pooled it
70.8field-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.

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
PMID 21883806PMID 19491535PMID 23010561PMID 22055210PMID 22193143PMID 21209033PMID 19491536PMID 25504028PMID 23186975PMID 21450987PMID 19245711PMID 19878259other papers from this trial
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
PMID 16776751PMID 18819705PMID 19915017PMID 19349323PMID 19930006PMID 11997279PMID 19815124PMID 20609967PMID 22586279PMID 22723560PMID 22949540PMID 19540343other papers from this trial
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NCT03421119 phase3unknown statusstarted 2019, after this paper: background citation

A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D)

Ran2019Enrolled300Registered outcomes12Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsLiraglutide 6 MG/ML Pen Injector, Metformin, Sulfonylurea/non-sulfonylurea insulin secretagogues
PMID 18931095PMID 19289857PMID 19515413PMID 19688338other papers from this trial
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3 · Its place in the literature

Who cites it

290 citing papers in PubMed, 18 syntheses or guidelines pooled it, 811 citations in OpenAlex.

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  5. 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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230 more citing papers are in PubMed but not listed here.

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 at 2 institutions in 2 countries.

M MarreService d'Endocrinologie Diabétologie Nutrition, Groupe Hospitalier Bichat-Claude Bernard, Paris, France. michel.marre@bch.ap-hop-paris.fr
J Shaw
M Brändle
W M W Bebakar
N A Kamaruddin
J Strand
M Zdravkovic
T D Le Thi
S Colagiuri
LEAD-1 SU study group
National University of Malaysia · MYUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all n >or= 228) or placebo (n = 114) with glimepiride (2-4 mg/day) on glycaemic control, body weight and safety in Type 2 diabetes.

methodsIn total, 1041 adults (mean +/- sd), age 56 +/- 10 years, weight 82 +/- 17 kg and glycated haemoglobin (HbA(1c)) 8.4 +/- 1.0% at 116 sites in 21 countries were stratified based on previous oral glucose-lowering mono : combination therapies (30 : 70%) to participate in a five-arm, 26-week, double-dummy, randomized study.

resultsLiraglutide (1.2 or 1.8 mg) produced greater reductions in HbA(1c) from baseline, (-1.1%, baseline 8.5%) compared with placebo (+0.2%, P < 0.0001, baseline 8.4%) or rosiglitazone (-0.4%, P < 0.0001, baseline 8.4%) when added to glimepiride. Liraglutide 0.6 mg was less effective (-0.6%, baseline 8.4%). Fasting plasma glucose decreased by week 2, with a 1.6 mmol/l decrease from baseline at week 26 with liraglutide 1.2 mg (baseline 9.8 mmol/l) or 1.8 mg (baseline 9.7 mmol/l) compared with a 0.9 mmol/l increase (placebo, P < 0.0001, baseline 9.5 mmol/l) or 1.0 mmol/l decrease (rosiglitazone, P < 0.006, baseline 9.9 mmol/l). Decreases in postprandial plasma glucose from baseline were greater with liraglutide 1.2 or 1.8 mg [-2.5 to -2.7 mmol/l (baseline 12.9 mmol/l for both)] compared with placebo (-0.4 mmol/l, P < 0.0001, baseline 12.7 mmol/l) or rosiglitazone (-1.8 mmol/l, P < 0.05, baseline 13.0 mmol/l). Changes in body weight with liraglutide 1.8 mg (-0.2 kg, baseline 83.0 kg), 1.2 mg (+0.3 kg, baseline 80.0 kg) or placebo (-0.1 kg, baseline 81.9 kg) were less than with rosiglitazone (+2.1 kg, P < 0.0001, baseline 80.6 kg). Main adverse events for all treatments were minor hypoglycaemia (< 10%), nausea (< 11%), vomiting (< 5%) and diarrhoea (< 8%).

conclusionsLiraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile.

Indexed as

AgedBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlucagon-Like Peptide 1HumansHypoglycemiaHypoglycemic AgentsMaleMiddle AgedRosiglitazoneSulfonylurea CompoundsThiazolidinedionesBlood GlucoseGlucagon-Like Peptide 1Hypoglycemic AgentsRosiglitazoneSulfonylurea CompoundsThiazolidinediones

Identifiers

PMID19317822
PMCPMC2871176
OpenAlexW2138290933

What Socratic holds

Textmetadata
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.