Evidence map›DPP-4 inhibitors × adverse events & safety›PMID 28786547›Full record

Trial reportDiabetes, obesity & metabolism2018

Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.

Yutaka Seino, Yasuo Terauchi, Takeshi Osonoi, Daisuke Yabe, Nobuyuki Abe, Tomoyuki Nishida, Jeppe Zacho, Shizuka Kaneko

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph read 1 number from its abstract, feeding 2 cells of the map, but none could be read as for or against, so it casts no vote. It reports registered trial NCT02254291. Cited by 60 papers, 10 of them syntheses that pooled it.

1number the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 10 pooled it
8.3field-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.

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

Adverse events & safetycomparator not stated · t2d, obesityfeeds 2 cells of the map
Δ -1.13-1.32 to -0.94P < .0001
The mean glycated haemoglobin (HbA1c [baseline 8.1%]) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, vs 0.7% with sitagliptin (estimated treatment difference [ETD] vs sitagliptin -1.13%, 95% confidence interval [CI] -1.32; -0.94, and -1.44%, 95% CI -1.63; -1.24; both P < .0001).
FeedsGLP-1 receptor agonists×adverse events & safetyDPP-4 inhibitors×adverse events & safety

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.

DPP-4 inhibitors×adverse events & safety

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

34 readable studies in this cell: 12 favour the treatment, 17 find no difference, 5 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 19 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT020991101,233 enrolled · 2014
Δ -3.20-11.7 to 5.50
NCT019301881,231 enrolled · 2013
Δ -1.06-1.21 to -0.91
NCT007344741,202 enrolled · 2008
Δ -0.71-0.87 to -0.55
NCT022730501,136 enrolled · 2014
Δ 0.00-2.30 to 2.30
NCT004499301,050 enrolled · 2007
Δ -7.30-10.6 to -4.20
NCT008389031,049 enrolled · 2009
Δ -0.35-0.53 to -0.17
NCT01023581784 enrolled · 2009
Δ -0.57-0.87 to -0.27
NCT01682759751 enrolled · 2012
Δ -6.90-13.9 to 0.10
NCT02738879746 enrolled · 2016
Δ -2.10-9.10 to 5.00
NCT01217073685 enrolled · 2010
Δ 6.20-6.20 to 18.4
NCT01890122647 enrolled · 2013
Δ -0.49-0.70 to -0.28

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

GLP-1 receptor agonists×adverse events & safety

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

40 readable studies in this cell: 47 favour the treatment, 14 find no difference, 2 favour the comparator.

Belief with this paper
0.02contested · 1 family supports, 41 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT017204463,297 enrolled · 2013
Δ -0.66-0.80 to -0.52
NCT036893742,274 enrolled · 2018
Δ -0.29-0.38 to -0.20
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
NCT008389031,049 enrolled · 2009
Δ -0.91-1.16 to -0.65
NCT009606611,036 enrolled · 2009
Δ -0.04-0.18 to 0.11
NCT050350821,018 enrolled · 2021
Δ -0.24-0.44 to -0.04
NCT01064687978 enrolled · 2010
Δ -1.05-1.22 to -0.88
NCT01117350978 enrolled · 2010
Δ 2.54-3.88 to 8.93

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

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.

NCT02254291 phase3completed

Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

Ran2014Enrolled308Registered outcomes3Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2Armssemaglutide, Sitagliptin
Open the trial in the graph
5 · Its place in the literature

Who cites it

60 citing papers in PubMed, 10 syntheses or guidelines pooled it, 119 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

8 authors at 7 institutions in 2 countries.

Yutaka SeinoKansai Electric Power Medical Research Institute, Kobe, Japan.ORCID 0000-0002-1099-7989
Yasuo TerauchiYokohama City University, Yokohama, Japan.
Takeshi OsonoiNaka Memorial Clinic, Ibaraki, Japan.
Daisuke YabeKansai Electric Power Medical Research Institute, Kobe, Japan.
Nobuyuki AbeAbe Clinic, Oita, Japan.
Tomoyuki NishidaNovo Nordisk Pharma Ltd, Tokyo, Japan.
Jeppe ZachoNovo Nordisk Pharma Ltd, Tokyo, Japan.
Shizuka KanekoTakatsuki Red Cross Hospital, Osaka, Japan.
Novo Nordisk (Denmark) · DKKansai Electric Power (Japan) · JPKyoto University · JPNakamura Memorial Hospital · JPOita Medical Center · JPTakatsuki Red Cross Hospital · JPYokohama City University · JP

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.

aimsTo assess the safety and efficacy of monotherapy with once-weekly subcutaneous (s.c.) semaglutide vs sitagliptin in Japanese people with type 2 diabetes (T2D).

methodsIn this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-daily oral sitagliptin 100 mg. The primary endpoint was number of treatment-emergent adverse events (TEAEs) after 30 weeks.

resultsOverall, 308 participants were randomized and exposed to treatment, with similar baseline characteristics across the groups. In total, 2.9% of participants in both the semaglutide 0.5 mg and the sitagliptin group prematurely discontinued treatment, compared with 14.7% in the semaglutide 1.0 mg group. The majority of discontinuations in the semaglutide 0.5 and 1.0 mg groups were attributable to adverse events (AEs). More TEAEs were reported in semaglutide- vs sitagliptin-treated participants (74.8%, 71.6% and 66.0% in the semaglutide 0.5 mg, semaglutide 1.0 mg and sitagliptin groups, respectively). AEs were mainly mild to moderate. Gastrointestinal AEs, most frequently reported with semaglutide, diminished in frequency over time. The mean glycated haemoglobin (HbA1c [baseline 8.1%]) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, vs 0.7% with sitagliptin (estimated treatment difference [ETD] vs sitagliptin -1.13%, 95% confidence interval [CI] -1.32; -0.94, and -1.44%, 95% CI -1.63; -1.24; both P < .0001). Body weight (baseline 69.3 kg) was reduced by 2.2 and 3.9 kg with semaglutide 0.5 and 1.0 mg, respectively (ETD -2.22 kg, 95% CI -3.02; -1.42 and -3.88 kg, 95% CI -4.70; -3.07; both P < .0001).

conclusionsIn Japanese people with T2D, more TEAEs were reported with semaglutide than with sitagliptin; however, the semaglutide safety profile was similar to that of other glucagon-like peptide-1 receptor agonists. Semaglutide significantly reduced HbA1c and body weight compared with sitagliptin.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAdministration, OralConstipationDiabetes Mellitus, Type 2DiarrheaDipeptidyl-Peptidase IV InhibitorsDose-Response Relationship, DrugDrug Administration ScheduleFollow-Up StudiesGlucagon-Like Peptide-1 ReceptorGlucagon-Like PeptidesGlycated HemoglobinHumansHyperglycemiaHypoglycemiaIncretinsDipeptidyl-Peptidase IV InhibitorsGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanIncretinsSemaglutideSitagliptin PhosphateGLP-1sitagliptintype 2 diabetes

Identifiers

PMID28786547
PMCPMC5813234
OpenAlexW2743930068

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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.