Trial reportThe Journal of clinical endocrinology and metabolism2015

Effect of vildagliptin on hepatic steatosis.

Mavin Macauley, Kieren G Hollingsworth, Fiona E Smith, Peter E Thelwall, Ahmad Al-Mrabeh, Anja Schweizer, James E Foley, Roy Taylor

Open access · bronzeFull text readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2015. The graph read 5 numbers from its abstract, feeding 3 cells of the map: it supports the treatment in 1, favours the comparator in 1. Cited by 50 papers, 5 of them syntheses that pooled it.

5numbers the graph read from it
3cells of the map it votes in
50citing papers in PubMed, 5 pooled it
12.5field-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.

← favours the treatmentfavours the comparator →
-3.400.300 · no effect
Glycemic controlfavours the comparator · against placebo · t2d, liverfeeds one cell of the map
change 0.10P < .0001
Mean HbA1c changed by -0.5 ± 0.1% (P < .0001) from a baseline of 6.5 ± 0.1% in the vildagliptin group, whereas a small numerical increase (0.2 ± 0.1% from a baseline of 6.4 ± 0.1%; P = .14) was seen in the placebo group, resulting in a significant between-group difference of -0.7 ± 0.1% (P < .001).
Body weight & compositionfavours the treatment · against placebo · t2d, liverfeeds one cell of the map
decrease -3.40P = .002
Mean body weight decreased by 1.6 ± 0.5 kg from a baseline of 82.6 ± 3.4 kg (P = .002) in the vildagliptin group and by 0.4 ± 0.5 kg from a baseline of 92.1 ± 2.5 kg (P = .41) in the placebo group over the study period.
Glycemic controlfavours the treatment · head-to-head · t2d, liverfeeds one cell of the map
decrease -1.00P = .018
Mean fasting plasma glucose concentration decreased over the study period with vildagliptin vs placebo by -1.0 mmol/L (P = .018), and there was a positive correlation between these decrements and liver triglyceride in the vildagliptin group at 3 months (r = 0.47; P = .02) and 6 months (r = 0.44; P = .03).
Lipidsno clear difference · head-to-head · t2d, liverfeeds one cell of the map
decrease -0.10P = .05
Mean fasting triglyceride decreased by 0.2 ± 0.1 mmol/L from a baseline of 1.5 ± 0.1 mmol/L (P = .05) in the vildagliptin group, compared to no change in the placebo group (0.0 ± 0.1 mmol/L from a baseline of 1.4 ± 0.1 mmol/L; P = .37).
Glycemic controlfavours the comparator · head-to-head · t2d, liverfeeds one cell of the map
change 0.30P = .001
Mean fasting plasma glucose changed by -0.9 ± 0.3 mmol/L (P = .001) in the vildagliptin group (baseline, 7.9 mmol/L) and by 0.2 ± 0.3 mmol/L (P = .24) in the placebo group (baseline, 7.5 ± 0.2 mmol/L) over the study period.

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×glycemic control

ContradictsOpen on the map →What to test next →

40 readable studies in this cell: 59 favour the treatment, 19 find no difference, 24 favour the comparator.

Belief with this paper
0.82replicated · 56 families support, 12 contradict · against placebo
Without it
0.84This paper moves it by −0.01.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2015
change 0.10
NCT015282542,004 enrolled · 2012
Slope -0.02-0.05 to 0.00
NCT026078651,864 enrolled · 2016
Δ -0.50-0.60 to -0.40
NCT001216671,462 enrolled · 2005
Δ -0.73-0.92 to -0.53
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.27-0.48 to -0.05
NCT004827291,246 enrolled · 2007
Δ -0.60-0.78 to -0.43
NCT020991101,233 enrolled · 2014
Δ -0.46-0.63 to -0.30
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 -0.21-0.41 to -0.02
NCT004499301,050 enrolled · 2007
Δ 0.140.06 to 0.21

DPP-4 inhibitors×body weight & composition

SupportsOpen on the map →What to test next →

29 readable studies in this cell: 8 favour the treatment, 8 find no difference, 13 favour the comparator.

Belief with this paper
0.50contested · 4 families support, 4 contradict · against placebo
Without it
0.43This paper moves it by +0.07.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2015
decrease -3.40
NCT026078651,864 enrolled · 2016
Δ -2.50-3.00 to -2.00
NCT011066771,284 enrolled · 2010
Δ -2.40-3.00 to -1.80
NCT007344741,202 enrolled · 2008
Δ -1.70-2.27 to -1.14
NCT007010901,035 enrolled · 2008
Δ -2.00-2.30 to -1.60
NCT00575588891 enrolled · 2007
Δ -2.20-2.70 to -1.70
NCT00676338820 enrolled · 2008
Δ -1.28-1.92 to -0.63
NCT00432276803 enrolled · 2007
Δ -0.50-1.03 to 0.04
NCT01137812756 enrolled · 2010
Δ -2.80-3.30 to -2.20
NCT01682759751 enrolled · 2012
IRR -3.70-10.6 to 3.30
NCT01438814689 enrolled · 2011
Δ 0.620.25 to 0.98
NCT02849080504 enrolled · 2016
Δ -1.90-2.60 to -1.20
NCT00642278451 enrolled · 2008
Δ 0.40-0.50 to 1.40

DPP-4 inhibitors×lipids

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

9 readable studies in this cell: 2 favour the treatment, 5 find no difference, 2 favour the comparator.

Belief with this paper
1.00replicated · 2 families support, 0 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
This paper · 2015
decrease -0.10
NCT011066771,284 enrolled · 2010
Δ 2.30-3.90 to 8.50
NCT00676338820 enrolled · 2008
Δ -0.22-0.41 to -0.03
NCT00432276803 enrolled · 2007
Δ -4.20-8.60 to 0.10
NCT01137812756 enrolled · 2010
Δ -2.30-9.80 to 5.30
NCT01106690344 enrolled · 2010
Δ -12.1-12.1 to -0.90
NCT01678820299 enrolled · 2012
Δ 0.40-4.80 to 5.60
NCT0220216170 enrolled · 2014
Δ 0.970.90 to 1.05
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

50 citing papers in PubMed, 5 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. An RNAi therapeutic targeting hepatic DGAT2 in a genetically obese mouse model of nonalcoholic steatohepatitis.Molecular therapy : the journal of the American Society of Gene Therapy · 2022
    Article
  20. Review
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 3 institutions in 3 countries.

Mavin MacauleyNewcastle Magnetic Resonance Centre (M.M., K.G.H., F.E.S., P.E.T., A.A.-M., R.T.), Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne NE4 5PL, United Kingdom; Novartis Pharma AG (A.S.), CH-4056 Basel, Switzerland; and Novartis Pharmaceutical (J.E.F.), East Hanover, New Jersey 07936.
Kieren G Hollingsworth
Fiona E Smith
Peter E Thelwall
Ahmad Al-Mrabeh
Anja Schweizer
James E Foley
Roy Taylor
Newcastle University · GBNovartis (Switzerland) · CHNovartis (United States) · 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.

contextAlthough dipeptidyl-peptidase-4 inhibitors exert their major action via an incretin mechanism, a favorable effect of vildagliptin on lipid metabolism remains unexplained.

objectiveThe objective was to examine hepatic triglyceride levels and insulin sensitivity on vildagliptin.

designThis was a 6-month, randomized, double-blind, placebo-controlled trial.

settingThis was an outpatient study at a university clinical research center. PATIENTS: Individuals with type 2 diabetes (n = 44) and glycated hemoglobin ≤ 7.6% on stable metformin therapy were included.

interventionIntervention was vildagliptin 50 mg twice a day or placebo over 6 months.

main outcome measuresMain outcome measures were hepatic triglyceride levels and insulin sensitivity.

resultsMean fasting liver triglyceride content decreased by 27% with vildagliptin, from 7.3 ± 1.0% (baseline) to 5.3 ± 0.9% (endpoint). There was no change in the placebo group. The between-group difference in change from baseline was significant (P = .013). Mean fasting plasma glucose concentration decreased over the study period with vildagliptin vs placebo by -1.0 mmol/L (P = .018), and there was a positive correlation between these decrements and liver triglyceride in the vildagliptin group at 3 months (r = 0.47; P = .02) and 6 months (r = 0.44; P = .03). Plasma alanine aminotransferase fell from 27.2 ± 2.8 to 20.3 ± 1.4 IU/L in the vildagliptin group (P = .0007), and there was a correlation between the decrements in alanine aminotransferase and liver triglyceride (r = 0.83; P < .0001). Insulin sensitivity during the euglycemic clamp was similar in each group at baseline (3.24 ± 0.30 vs 3.19 ± 0.38 mg/kg/min) and did not change (adjusted mean change of 0.26 ± 0.22 vs 0.32 ± 0.22 mg/kg/min; P = .86). Mean body weight decreased by 1.6 ± 0.5 vs 0.4 ± 0.5 kg in the vildagliptin and placebo groups, respectively (P = .08).

conclusionsThis study demonstrates that the dipeptidyl-peptidase-4 inhibitor vildagliptin brings about a clinically significant decrease in hepatic triglyceride levels during 6 months of therapy unrelated to change in body weight. There was no change in peripheral insulin sensitivity.

Indexed as

AdamantaneAgedDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDrug Administration ScheduleFatty LiverFemaleGlycated HemoglobinHumansHypoglycemic AgentsLiverMaleMetforminMiddle AgedNitrilesPyrrolidinesAdamantaneDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminNitrilesPyrrolidinesTriglyceridesVildagliptin

Identifiers

PMID25664602
PMCPMC4399299
OpenAlexW1974811153

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.