Evidence map›Insulin × body weight & composition›PMID 25980900›Full record

Trial reportDiabetes, obesity & metabolism2015

One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.

S C L Gough, B W Bode, V C Woo, H W Rodbard, S Linjawi, M Zacho, P D Reiter, J B Buse

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

Trial report in Diabetes, obesity & metabolism, 2015. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. It reports registered trial NCT01336023. Cited by 52 papers, 5 of them syntheses that pooled it.

1number the graph read from it
0cells of the map it votes in
52citing 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.

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

Body weight & compositioncomparator not stated · t2d, obesityfeeds one cell of the map
Δ -2.80p < 0.0001
IDegLira was associated with a significantly greater decrease in body weight (estimated treatment difference, -2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec.
FeedsInsulin×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.

Insulin×body weight & composition

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

12 readable studies in this cell: 1 favour the treatment, 1 find no difference, 10 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 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
NCT037306622,002 enrolled · 2018
Δ -9.00-9.80 to -8.30
NCT038829701,444 enrolled · 2019
Δ -9.80-10.8 to -8.80
NCT045379231,428 enrolled · 2020
Δ -10.7-11.5 to -9.90
NCT020581471,170 enrolled · 2014
Δ 40.633.6 to 47.6
NCT04093752917 enrolled · 2019
Δ -6.50-7.40 to -5.60
NCT01768559894 enrolled · 2013
Δ -1.99-2.59 to -1.40
NCT01075282810 enrolled · 2010
Δ 2.832.33 to 3.33
NCT02551874650 enrolled · 2015
Δ -3.64-4.20 to -3.09
Liraglutide vs insulin glargine and placebo in combination with metfor…PMID 19688338 · 584 enrolled · 2006
Δ 2.86
Weight Gain Was Associated With Worsening Glycemia and Cardiovascular …PMID 40267365 · 2025
Δ 0.450.16 to 0.74
Continuing metformin when starting insulin in patients with Type 2 dia…PMID 15842521 · 2005
Δ 1.500.20 to 2.90

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.

NCT01336023 phase3completed

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Ran2011Enrolled1,663Registered outcomes5Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin degludec/liraglutide, liraglutide
PMID 28282219PMID 25190523PMID 26443290PMID 25998481PMID 28417535PMID 26894800PMID 28332144other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

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

  1. Guideline
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  6. Trial
  7. Trial
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  11. Trial
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  14. Review
  15. Article
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  19. Cost-Effectiveness of iGlarLixi in People with Type 2 Diabetes Mellitus Suboptimally Controlled on Basal Insulin Plus Metformin in the UK.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  20. Article
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.

S C L GoughOxford Centre for Diabetes, Endocrinology and Metabolism, and NIHR Oxford Biomedical Research Centre, Churchill Hospital, Oxford, UK.
B W BodeAtlanta Diabetes Associates, Atlanta, GA, USA.
V C WooDepartment of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.
H W RodbardEndocrine and Metabolic Consultants, Rockville, MD, USA.
S LinjawiCoffs Harbour Diabetes Clinic, Coffs Harbour, NSW, Australia.
M ZachoNovo Nordisk A/S, Søborg, Denmark.
P D ReiterNovo Nordisk A/S, Søborg, Denmark.
J B BuseDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.

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 confirm, in a 26-week extension study, the sustained efficacy and safety of a fixed combination of insulin degludec and liraglutide (IDegLira) compared with either insulin degludec or liraglutide alone, in patients with type 2 diabetes.

methodsInsulin-naïve adults with type 2 diabetes randomized to once-daily IDegLira, insulin degludec or liraglutide, in addition to metformin ± pioglitazone, continued their allocated treatment in this preplanned 26-week extension of the DUAL I trial.

resultsA total of 78.8% of patients (1311/1663) continued into the extension phase. The mean glycated haemoglobin (HbA1c) concentration at 52 weeks was reduced from baseline by 1.84% (20.2 mmol/mol) for the IDegLira group, 1.40% (15.3 mmol/mol) for the insulin degludec group and 1.21% (13.2 mmol/mol) for the liraglutide group. Of the patients on IDegLira, 78% achieved an HbA1c of <7% (53 mmol/mol) versus 63% of the patients on insulin degludec and 57% of those on liraglutide. The mean fasting plasma glucose concentration at the end of the trial was similar for IDegLira (5.7 mmol/l) and insulin degludec (6.0 mmol/l), but higher for liraglutide (7.3 mmol/l). At 52 weeks, the daily insulin dose was 37% lower with IDegLira (39 units) than with insulin degludec (62 units). IDegLira was associated with a significantly greater decrease in body weight (estimated treatment difference, -2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec. Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira.

conclusionsThese 12-month data, derived from a 26-week extension of the DUAL I trial, confirm the initial 26-week main phase results and the sustainability of the benefits of IDegLira compared with its components in glycaemic efficacy, safety and tolerability.

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug Therapy, CombinationFastingFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin, Long-ActingLiraglutideMaleMetforminMiddle AgedBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agentsinsulin degludecInsulin, Long-ActingLiraglutideMetforminPioglitazoneThiazolidinedionesdiabetes therapyhypoglycaemiainsulin degludecliraglutide

Identifiers

PMID25980900
PMCPMC4744775

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.