Evidence map›GLP-1 receptor agonists × glycemic control›PMID 26816604›Full record

Trial reportJournal of diabetes investigation2016

Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial.

Kohei Kaku, Arihiro Kiyosue, Yuri Ono, Toshihiko Shiraiwa, Shizuka Kaneko, Keiji Nishijima, Heidrun Bosch-Traberg, Yutaka Seino

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2016. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it . An erratum has been issued. It reports registered trial NCT01512108. Cited by 15 papers, 5 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
15citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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 →
-10.80 · no effect
Glycosylated hemoglobinpretrial OAD in combination with liraglutide 0.9 mg/day vs pretrial OAD in combination with an additional OADfavours the treatment · t2dfeeds one cell of the map
Δ -0.27-0.44 to -0.09P = 0.0026
Mean reductions in glycosylated hemoglobin were significantly greater in the liraglutide group than the additional OAD group [estimated mean treatment difference -0.27% (95% confidence interval (CI) -0.44, -0.09; P = 0.0026)]; reductions in mean fasting plasma glucose levels were also greater with liraglutide [estimated mean difference -5.47 mg/dL (-0.30 mmol/L; 95% CI: -10.83, -0.10; P = 0.0458)].
FeedsGLP-1 receptor agonists×glycemic control
Fasting plasma glucose levelspretrial OAD in combination with liraglutide 0.9 mg/day vs pretrial OAD in combination with an additional OADfavours the treatment · t2dfeeds one cell of the map
Δ -5.47-10.8 to -0.10
Mean reductions in glycosylated hemoglobin were significantly greater in the liraglutide group than the additional OAD group [estimated mean treatment difference -0.27% (95% confidence interval (CI) -0.44, -0.09; P = 0.0026)]; reductions in mean fasting plasma glucose levels were also greater with liraglutide [estimated mean difference -5.47 mg/dL (-0.30 mmol/L; 95% CI: -10.83, -0.10; P = 0.0458)].
FeedsGLP-1 receptor agonists×glycemic control

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: 97 favour the treatment, 16 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 resultNCT01512108 · 363 enrolled · 2012
Δ -0.27-0.44 to -0.09
This paper · 2016
Δ -0.27-0.44 to -0.09
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.

NCT01512108 phase3completed

A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy

Ran2012Enrolled363Registered outcomes4Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, oral anti-diabetic drug
PMID 28984041other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

15 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. A Network Meta-Analysis Comparing Semaglutide Once-Weekly with Other GLP-1 Receptor Agonists in Japanese Patients with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Article
  14. Clinical Effectiveness of Liraglutide in Type 2 Diabetes Treatment in the Real-World Setting: A Systematic Literature Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016
    Review
  15. Article
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

8 authors.

Kohei KakuDepartment of Internal Medicine Kawasaki Medical School Okayama Japan.
Arihiro KiyosueTokyo-Eki Center-building Clinic Tokyo Japan.
Yuri OnoYuri Ono Clinic Hokkaido Japan.
Toshihiko ShiraiwaShiraiwa Medical Clinic Osaka Japan.
Shizuka KanekoTakatsuki Red Cross Hospital Osaka Japan.
Keiji NishijimaMedical & Scientific Affairs Department Novo Nordisk Pharma Ltd Tokyo Japan.
Heidrun Bosch-TrabergMedical and Science GLP-1 Novo Nordisk A/S Søborg Denmark.
Yutaka SeinoKansai Electric Power Hospital Osaka Japan.

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.

introductionThe safety and efficacy of liraglutide in combination with an oral antidiabetic drug (OAD) compared with combination of two OADs were assessed in Japanese patients with type 2 diabetes. MATERIALS AND

methodsThis was a 52-week, open-label, parallel-group trial in which patients whose type 2 diabetes was inadequately controlled with a single OAD (glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) were randomized 2:1 to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group; n = 240) or pretrial OAD in combination with an additional OAD (additional OAD group; n = 120). The primary outcome measure was the incidence of adverse events (AEs).

resultsOverall, 86.3% of patients in the liraglutide group and 85.0% of patients in the additional OAD group experienced AEs; these were similar in nature and severity. Adverse event rates were 361 and 331 per 100 patient-years of exposure, respectively. Confirmed hypoglycemia was rare (seven episodes in two patients on liraglutide, and two in two patients on additional OAD). There were no reported pancreatitis events, and no unexpected safety signals were identified. Mean reductions in glycosylated hemoglobin were significantly greater in the liraglutide group than the additional OAD group [estimated mean treatment difference -0.27% (95% confidence interval (CI) -0.44, -0.09; P = 0.0026)]; reductions in mean fasting plasma glucose levels were also greater with liraglutide [estimated mean difference -5.47 mg/dL (-0.30 mmol/L; 95% CI: -10.83, -0.10; P = 0.0458)].

conclusionsLiraglutide was well tolerated and effective as combination therapy with an OAD in Japanese patients with type 2 diabetes.

Indexed as

Asian PeopleAdministration, OralAgedDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleHumansHypoglycemic AgentsJapanLiraglutideMaleMetforminMiddle AgedTreatment OutcomeHypoglycemic AgentsLiraglutideMetforminLiraglutideOral antidiabetic drugType 2 diabetes mellitus

Identifiers

PMID26816604
PMCPMC4718097

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.