Trial reportJournal of diabetes science and technology2015

IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test.

Jens J Holst, John B Buse, Helena W Rodbard, Sultan Linjawi, Vincent C Woo, Trine Welløv Boesgaard, Kajsa Kvist, Stephen C Gough

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2015. The graph read 4 numbers from its abstract, feeding 1 cell of the map, but it casts no vote: it is a later paper about NCT01336023, whose primary report (PMID 25190523) speaks for the trial. It reports registered trial NCT01336023. Cited by 12 papers.

4numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.7field-weighted citation impact, top 9% 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 →
-21.16.670 · no effect
Change from baseline in PPG increment (iAUC0-4h)IDegLira vs liraglutideno clear difference · t2dfeeds one cell of the map
Δ -1.80-2.52 to 5.95
CGM indicated a greater reduction in change from baseline in PPG increment (iAUC0-4h) for IDegLira versus insulin degludec over all 3 main meals (ETD -6.13 mg/dl [95% CI: -10.27, -1.98], P = .0047) and similar reductions versus liraglutide (ETD -1.80 mg/dl [95% CI: -2.52, 5.95], P = .4122).
Change from baseline in PPG increment (iAUC0-4h)IDegLira vs insulin degludecfavours the treatment · t2dfeeds one cell of the map
Δ -6.13-10.3 to -1.98
CGM indicated a greater reduction in change from baseline in PPG increment (iAUC0-4h) for IDegLira versus insulin degludec over all 3 main meals (ETD -6.13 mg/dl [95% CI: -10.27, -1.98], P = .0047) and similar reductions versus liraglutide (ETD -1.80 mg/dl [95% CI: -2.52, 5.95], P = .4122).
Mean PPG increment (normalized iAUC0-4h)IDegLira vs insulin degludecfavours the treatment · t2dfeeds one cell of the map
Δ -12.8-21.1 to -4.68P = .0023
RESULTS: At week 26, IDegLira produced a significantly greater decrease from baseline in mean PPG increment (normalized iAUC0-4h) than insulin degludec (estimated treatment difference [ETD] -12.79 mg/dl [95% CI: -21.08; -4.68], P = .0023) and a similar magnitude of decrease as liraglutide (ETD -1.62 mg/dl [95% CI: -10.09; 6.67], P = .70).
Mean PPG increment (normalized iAUC0-4h)IDegLira vs liraglutideno clear difference · t2dfeeds one cell of the map
Δ -1.62-10.1 to 6.67
RESULTS: At week 26, IDegLira produced a significantly greater decrease from baseline in mean PPG increment (normalized iAUC0-4h) than insulin degludec (estimated treatment difference [ETD] -12.79 mg/dl [95% CI: -21.08; -4.68], P = .0023) and a similar magnitude of decrease as liraglutide (ETD -1.62 mg/dl [95% CI: -10.09; 6.67], P = .70).

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×glycemic control

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

40 readable studies in this cell: 14 favour the treatment, 14 find no difference, 13 favour the comparator.

Belief with this paper
0.50contested · 9 families support, 6 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 resultNCT01336023 · 1,663 enrolled · 2011
Treatment contrast -0.64-0.75 to -0.53
NCT036893742,274 enrolled · 2018
Δ -0.29-0.38 to -0.20
NCT037306622,002 enrolled · 2018
Δ -0.99-1.13 to -0.86
NCT038829701,444 enrolled · 2019
Δ -0.86-1.00 to -0.72
NCT045379231,428 enrolled · 2020
Δ -1.10-1.24 to -0.97
NCT032680051,264 enrolled · 2017
Δ -0.04-0.11 to 0.03
NCT020581471,170 enrolled · 2014
Δ -0.78-0.90 to -0.67
NCT021289321,089 enrolled · 2014
Δ -0.81-0.96 to -0.67
NCT009606611,036 enrolled · 2009
Δ -0.04-0.18 to 0.11
NCT00856986987 enrolled · 2009
Δ -0.52-0.68 to -0.36
NCT01117350978 enrolled · 2010
Δ 2.54-3.88 to 8.93
NCT03214380933 enrolled · 2017
Δ 0.06-0.05 to 0.16
NCT04093752917 enrolled · 2019
Δ -1.49-1.69 to -1.29
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
Open the trial in the graph
5 · Its place in the literature

Who cites it

12 citing papers in PubMed, 26 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 6 institutions in 5 countries.

Jens J HolstNNF Center for Basic Metabolic Research and Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark jjholst@sund.ku.dk holst@mfi.ku.dk.
John B BuseUniversity of North Carolina, Chapel Hill, NC, USA.
Helena W RodbardEndocrine and Metabolic Consultants, Rockville, MD, USA.
Sultan LinjawiCoffs Harbour Diabetes Clinic, Coffs Harbour, Australia.
Vincent C WooUniversity of Manitoba, Winnipeg, MB, Canada.
Trine Welløv BoesgaardNovo Nordisk A/S, Søborg, Denmark.
Kajsa KvistNovo Nordisk A/S, Søborg, Denmark.
Stephen C GoughOxford Centre for Diabetes, Endocrinology and Metabolism, and NIHR Oxford Biomedical Research Centre, Churchill Hospital, Oxford, UK.
Novo Nordisk (Denmark) · DKChurchill Hospital · GBCoffs Harbour City Council · AUUniversity of Copenhagen · DKUniversity of Manitoba · CAUniversity of North Carolina at Chapel Hill · US

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.

objectiveIDegLira is a novel, fixed-ratio combination of the long-acting basal insulin, insulin degludec, and the long-acting glucagon-like peptide-1 analog liraglutide. We studied the effect of IDegLira versus its components on postprandial glucose (PPG) in type 2 diabetes.

methodsIn this substudy, 260 (15.6%) of the original 1663 patients with inadequate glycemic control participating in a 26-week, open-label trial (DUAL I) were randomized 2:1:1 to once-daily IDegLira, insulin degludec or liraglutide. Continuous glucose monitoring (CGM) for 72 hours and a meal test were performed.

resultsAt week 26, IDegLira produced a significantly greater decrease from baseline in mean PPG increment (normalized iAUC0-4h) than insulin degludec (estimated treatment difference [ETD] -12.79 mg/dl [95% CI: -21.08; -4.68], P = .0023) and a similar magnitude of decrease as liraglutide (ETD -1.62 mg/dl [95% CI: -10.09; 6.67], P = .70). CGM indicated a greater reduction in change from baseline in PPG increment (iAUC0-4h) for IDegLira versus insulin degludec over all 3 main meals (ETD -6.13 mg/dl [95% CI: -10.27, -1.98], P = .0047) and similar reductions versus liraglutide (ETD -1.80 mg/dl [95% CI: -2.52, 5.95], P = .4122). Insulin secretion ratio and static index were greater for IDegLira versus insulin degludec (P = .048 and P = .006, respectively) and similar to liraglutide (P = .45 and P = .895, respectively).

conclusionsOnce-daily IDegLira provides significantly better PPG control following a mixed meal test than insulin degludec. The improvement is at least partially explained by higher endogenous insulin secretion and improved beta cell function with IDegLira. The benefits of liraglutide on PPG control are maintained across all main meals in the combination.

Indexed as

AdultAgedBlood GlucoseDiabetes Mellitus, Type 2Drug CombinationsFastingFemaleHumansHypoglycemic AgentsInsulin, Long-ActingLiraglutideMaleMiddle AgedMonitoring, PhysiologicPostprandial PeriodBlood GlucoseDrug CombinationsHypoglycemic Agentsinsulin degludecInsulin, Long-ActingLiraglutidecombination therapydiabetes therapyincretinsinsulin degludecliraglutidepostprandial glucosequality of glycemic control

Identifiers

PMID26443290
PMCPMC4773967
OpenAlexW2207883647

What OpenQuestion 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 OpenQuestion graph.