Evidence map›Paper›PMID 29322610›Full record

Trial reportDiabetes, obesity & metabolism2018

Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.

Kohei Kaku, Yuichiro Yamada, Hirotaka Watada, Atsuko Abiko, Tomoyuki Nishida, Jeppe Zacho, Arihiro Kiyosue

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 could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02207374. Cited by 69 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 15 pooled it
8.8field-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.

NCT02207374 phase3completed

Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

Ran2014Enrolled601Registered outcomes3Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsDPP-4 inhibitor, semaglutide
PMID 29748996PMID 29907893other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 15 syntheses or guidelines pooled it, 122 citations in OpenAlex.

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9 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

7 authors at 5 institutions in 1 country.

Kohei KakuDepartment of General Internal Medicine 1, Kawasaki Medical School, Okayama, Japan.ORCID 0000-0003-1574-0565
Yuichiro YamadaDepartment of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Akita, Japan.
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Atsuko AbikoDepartment of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan.
Tomoyuki NishidaNovo Nordisk Pharma Ltd., Tokyo, Japan.
Jeppe ZachoNovo Nordisk Pharma Ltd., Tokyo, Japan.
Arihiro KiyosueDepartment of Internal Medicine, Tokyo-Eki Center-Building Clinic, Tokyo, Japan.
Akita University · JPAsahikawa Medical University · JPJuntendo University · JPKawasaki Medical School · JPMinamiaoyama Eye Clinic · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the safety and efficacy of once-weekly subcutaneous semaglutide as monotherapy or combined with an oral antidiabetic drug (OAD) vs an additional OAD added to background therapy in Japanese people with type 2 diabetes (T2D) inadequately controlled on diet/exercise or OAD monotherapy.

methodsIn this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy. The primary endpoint was number of adverse events (AEs) after 56 weeks.

resultsBaseline characteristics were balanced between treatment arms (601 randomized). More AEs were reported in the semaglutide 0.5 mg (86.2%) and 1.0 mg (88.0%) groups than in the additional OAD group (71.7%). These were typically mild/moderate. Gastrointestinal AEs were most frequent with semaglutide, which diminished over time. The mean glycated haemoglobin (HbA1c) concentration (baseline 8.1%) was significantly reduced with semaglutide 0.5 mg and 1.0 mg vs additional OAD (1.7% and 2.0% vs 0.7%, respectively; estimated treatment difference [ETD] vs additional OAD -1.08% and -1.37%, both P < .0001). Body weight (baseline 71.5 kg) was reduced by 1.4 kg and 3.2 kg with semaglutide 0.5 mg and 1.0 mg, vs a 0.4-kg increase with additional OAD (ETD -1.84 kg and -3.59 kg; both P < .0001). For semaglutide-treated participants, >80% achieved an HbA1c concentration <7.0% (Japanese Diabetes Society target).

conclusionsSemaglutide was well tolerated, with no new safety issues identified. Semaglutide treatment significantly reduced HbA1c and body weight vs additional OAD treatment in Japanese people with T2D.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAdministration, OralAgedCombined Modality TherapyDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug Administration ScheduleDrug MonitoringDrug ResistanceDrug Therapy, CombinationFemaleFollow-Up StudiesGlucagon-Like Peptide-1 ReceptorGlucagon-Like PeptidesGlycated HemoglobinHumansGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSemaglutideGLP-1 analogueglycaemic controlincretin therapyphase III studyrandomized trialtype 2 diabetes

Identifiers

PMID29322610
PMCPMC5969242
OpenAlexW2784318050

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.