Evidence map›GLP-1 receptor agonists × glycemic control›PMID 20199137›Full record

Trial reportCurrent medical research and opinion2010

Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes.

Y Seino, M F Rasmussen, T Nishida, K Kaku

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Current medical research and opinion, 2010. The graph read 3 numbers from its abstract, feeding 4 cells of the map: it finds no clear difference in 2. It reports registered trial NCT00393718. Cited by 57 papers, 11 of them syntheses that pooled it.

3numbers the graph read from it
2cells of the map it votes in
57citing papers in PubMed, 11 pooled it
8.9field-weighted citation impact, top 2% 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 →
-1.000.300 · no effect
Glycemic controlfavours the treatment · head-to-head · obesity, t2dfeeds 2 cells of the map
Δ -0.72-1.00 to -0.40p < 0.0001
Mean fasting plasma glucose (FPG) levels at 24 weeks were significantly lower with liraglutide (7.6 mmol/l [SE +/- 0.1]) vs glibenclamide (8.3 mmol/l [+/-0.1]; difference, -0.72 mmol/l; 95% CI -1.0 to -0.4; p < 0.0001).
FeedsGLP-1 receptor agonists×glycemic controlSulfonylureas & glinides×glycemic control
Glycemic controlno clear difference · against placebo · obesity, t2dfeeds 2 cells of the map
Δ -0.50-0.70 to 0.30p < 0.0001
RESULTS: After 24 weeks, glycaemic control with liraglutide was non-inferior/superior to glibenclamide, with HbA(1C) at 24 weeks of 6.99% (SE +/- 0.07) with liraglutide and 7.50% (+/-0.09) with glibenclamide (difference, -0.5%; 95% CI -0.70 to 0.30; p < 0.0001).
FeedsGLP-1 receptor agonists×glycemic controlSulfonylureas & glinides×glycemic control

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

Body weight & compositioncomparator not stated · obesity, t2dfeeds 2 cells of the map
Δ -1.91-2.34 to -1.48p < 0.0001
Weight was reduced by -0.92 kg from a baseline of 65.2 kg in liraglutide-treated patients, compared with weight gain of +0.99 kg from a baseline of 64.8 kg with glibenclamide (difference, -1.91 kg; 95% CI -2.34 to -1.48; p < 0.0001).
FeedsGLP-1 receptor agonists×body weight & compositionSulfonylureas & glinides×body weight & composition

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

InconclusiveOpen 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 paper400 enrolled · 2006
Δ -0.50-0.70 to 0.30
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

Sulfonylureas & glinides×glycemic control

InconclusiveOpen on the map →What to test next →

31 readable studies in this cell: 7 favour the treatment, 14 find no difference, 10 favour the comparator.

Belief with this paper
0.83established · 5 families support, 1 contradict · against placebo
Without it
0.83This paper does not move the number.
← favours the comparatorfavours the treatment →
0 · no effect
This paper400 enrolled · 2006
Δ -0.50-0.70 to 0.30
NCT017093055,570 enrolled · 2012
Δ 0.190.02 to 0.36
NCT009688121,452 enrolled · 2009
Δ -0.01-0.11 to 0.09
NCT006609071,217 enrolled · 2008
Δ 0.00-0.11 to 0.11
NCT003184611,091 enrolled · 2006
Δ -0.02-0.19 to 0.15
NCT008389031,049 enrolled · 2009
Δ -0.27-0.45 to -0.09
The study to understand the genetics of the acute response to metformi…PMID 25812009 · 1,033 enrolled · 2008
Δ 0.640.33 to 0.95
NCT03332771954 enrolled · 2017
Δ 0.12-0.12 to 0.36
NCT02471404939 enrolled · 2015
Δ 0.160.03 to 0.30
NCT00614120929 enrolled · 2008
Δ -0.06-0.23 to 0.11
NCT00575588891 enrolled · 2007
Δ 0.06-0.05 to 0.16
NCT01682759751 enrolled · 2012
Δ 0.180.06 to 0.30
NCT00294723746 enrolled · 2006
Δ -0.62-0.83 to -0.42

GLP-1 receptor agonists×body weight & composition

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

40 readable studies in this cell: 83 favour the treatment, 15 find no difference, 11 favour the comparator.

Belief with this paper
0.90replicated · 64 families support, 7 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
This paper’s trial, registry resultNCT00393718 · 400 enrolled · 2006
Least Squares Mean -1.91-2.34 to -1.48
NCT012722193,731 enrolled · 2011
Δ -5.39-5.82 to -4.95
Coadministered Cagrilintide and Semaglutide in Adults with Overweight …PMID 40544433 · 3,400 enrolled · 2022
Δ -17.3-18.1 to -16.6
NCT017204463,297 enrolled · 2013
Δ -2.95-3.47 to -2.44
NCT035489351,961 enrolled · 2018
Δ -12.4-13.4 to -11.5
NCT039879191,879 enrolled · 2019
Δ -1.70-2.60 to -0.70
NCT026078651,864 enrolled · 2016
Δ -2.50-3.00 to -2.00
NCT056467061,407 enrolled · 2023
Δ -14.8-16.2 to -13.4
NCT018365231,398 enrolled · 2013
Δ -4.90-5.65 to -4.16
NCT035527571,210 enrolled · 2018
Δ -6.21-7.28 to -5.15
NCT007344741,202 enrolled · 2008
Δ -1.50-2.08 to -0.92
Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type…PMID 40544432 · 1,200 enrolled · 2023
Δ -10.4-11.2 to -9.50
NCT020581471,170 enrolled · 2014
Δ 14.38.37 to 20.3

Sulfonylureas & glinides×body weight & composition

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

15 readable studies in this cell: 2 favour the treatment, 1 find no difference, 12 favour the comparator.

Belief with this paper
0.27contested · 1 family supports, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
This paper’s trial, registry resultNCT00393718 · 400 enrolled · 2006
Least Squares Mean -1.91-2.34 to -1.48
NCT009688121,452 enrolled · 2009
Δ -5.20-5.70 to -4.70
NCT006609071,217 enrolled · 2008
Δ -4.65-5.14 to -4.17
NCT003184611,091 enrolled · 2006
Δ -3.75-4.48 to -3.01
NCT03332771954 enrolled · 2017
Δ -3.58-4.65 to -2.52
NCT02471404939 enrolled · 2015
Δ -5.30-5.93 to -4.67
NCT00575588891 enrolled · 2007
Δ -2.20-2.70 to -1.70
NCT01682759751 enrolled · 2012
IRR -3.70-10.6 to 3.30
NCT00294723746 enrolled · 2006
Δ -3.58-4.28 to -2.87
NCT02033889621 enrolled · 2013
Δ -1.60-2.16 to -1.03
NCT02419612444 enrolled · 2015
Δ -4.06-4.84 to -3.28
NCT02564926125 enrolled · 2016
Δ -2.60-3.35 to -1.82
NCT0062028249 enrolled · 2008
Least squares mean -2.86-4.14 to -1.58
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.

NCT00393718 phase3completed

Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes

Ran2006Enrolled400Registered outcomes13Posted comparisons15ConditionsDiabetes, Diabetes Mellitus, Type 2Armsglibenclamide, liraglutide, Placebo
PMID 23010561PMID 24843595other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

57 citing papers in PubMed, 11 syntheses or guidelines pooled it, 113 citations in OpenAlex.

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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

4 authors at 3 institutions in 2 countries.

Y SeinoKansai Electric Power Hospital, Osaka, Japan. seino.yutaka@e2.kepco.co.jp
M F Rasmussen
T Nishida
K Kaku
Kansai Electric Power Hospital · JPKawasaki Medical School · JPNovo Nordisk (Denmark) · DK

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.

objectiveLiraglutide is a once-daily human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes mellitus (T2DM). In Phase 2 and Phase 3 trials, largely conducted in populations of European descent, liraglutide has been shown to lower HbA(1C), weight and systolic blood pressure with a low risk of hypoglycaemia. This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy. RESEARCH DESIGN AND

methodsA total of 411 Japanese subjects were randomised 2:1 to liraglutide (n = 272) or glibenclamide (n = 139). Liraglutide was administered at a maximum planned dose of 0.9 mg once daily. Glibenclamide was administered once or twice daily at a planned maximum dose of 2.5 mg/day, before or after meals. CLINICAL

trial registrationNCT00393718.

resultsAfter 24 weeks, glycaemic control with liraglutide was non-inferior/superior to glibenclamide, with HbA(1C) at 24 weeks of 6.99% (SE +/- 0.07) with liraglutide and 7.50% (+/-0.09) with glibenclamide (difference, -0.5%; 95% CI -0.70 to 0.30; p < 0.0001). Mean fasting plasma glucose (FPG) levels at 24 weeks were significantly lower with liraglutide (7.6 mmol/l [SE +/- 0.1]) vs glibenclamide (8.3 mmol/l [+/-0.1]; difference, -0.72 mmol/l; 95% CI -1.0 to -0.4; p < 0.0001). Weight was reduced by -0.92 kg from a baseline of 65.2 kg in liraglutide-treated patients, compared with weight gain of +0.99 kg from a baseline of 64.8 kg with glibenclamide (difference, -1.91 kg; 95% CI -2.34 to -1.48; p < 0.0001). A significantly lower rate of minor hypoglycaemic episodes was achieved with liraglutide compared with glibenclamide (p < 0.0001), and no major hypoglycaemic episodes were reported in either treatment group. The most common gastrointestinal AEs were diarrhoea (liraglutide, 6.3%; glibenclamide, 3.8%) and constipation (liraglutide, 5.6%; glibenclamide, 3.8%). Nausea was infrequent (liraglutide, 4.5%; glibenclamide, 1.5%).

conclusionsLiraglutide monotherapy, administered once daily for 24 weeks in Japanese subjects with T2DM, was well tolerated. Compared with glibenclamide monotherapy, liraglutide achieved superior glycaemic control and weight outcome, and a significantly lower incidence of hypoglycaemia. Future studies, comprising a greater proportion of true therapy-naïve Japanese patients, will be beneficial in order to establish the true add-on efficacy of liraglutide monotherapy in patients with T2DM.

Indexed as

Blood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleGlucagon-Like Peptide 1GlyburideGlycated HemoglobinHumansHypoglycemic AgentsLipidsLiraglutidePlacebosBlood GlucoseGlucagon-Like Peptide 1GlyburideGlycated HemoglobinHypoglycemic AgentsLipidsLiraglutidePlacebos

Identifiers

PMID20199137
OpenAlexW2012425163

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.