Trial reportDiabetes, obesity & metabolism2014

Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.

V Lukashevich, S Del Prato, M Araga, W Kothny

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2014. The graph read 3 numbers from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

3numbers the graph read from it
1cell of the map it votes in
33citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 4% 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 →
-1.130 · no effect
Glycemic controlfavours the treatment · against placebo · obesity, t2dfeeds one cell of the map
Δ -0.97p < 0.001
In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between-treatment difference: -0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014).
Glycemic controlfavours the treatment · against placebo · obesity, t2dfeeds one cell of the map
Δ -0.76p < 0.001
RESULTS: After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was -1.01% with vildagliptin (baseline 8.75%) and -0.25% with placebo (baseline 8.80%), with a between-treatment difference of -0.76% (p < 0.001).
Glycemic controlfavours the treatment · head-to-head · obesity, t2dfeeds one cell of the map
reduction -1.13p < 0.001
The difference in fasting plasma glucose reduction between vildagliptin and placebo was -1.13 mmol/l (p < 0.001).

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

SupportsOpen 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
0.82This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2014
Δ -0.97
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
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.

NCT04841096 phase3completedstarted 2023, after this paper: background citation

Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure

Ran2023Enrolled162Registered outcomes5Posted comparisons0ConditionsType 2 DiabetesArmsA1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg), (A2) Glimepiride/Vildagliptin/Metformin, (B2) Glimepiride/Vildagliptin/Metformin, B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
Open the trial in the graph
NCT01233622 phase3completednot on this map

A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes

TypeinterventionalSponsorNovartisRan2010 to 2011Enrolled317ConditionsType 2 Diabetes MellitusArmsVildagliptin, Placebo
5 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Japanese Clinical Practice Guideline for Diabetes 2019.Journal of diabetes investigation · 2020
    Article
  14. Efficacy of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion (CSII) in Hospitalized Patients with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Japanese Clinical Practice Guideline for Diabetes 2016.Journal of diabetes investigation · 2018
    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

4 authors at 2 institutions in 2 countries.

V LukashevichNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
S Del Prato
M Araga
W Kothny
Tris Pharma (United States) · USUniversity of Pisa · IT

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.

aimThe broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add-on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control.

methodsA multicentre, double-blind, placebo-controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.

resultsAfter 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was -1.01% with vildagliptin (baseline 8.75%) and -0.25% with placebo (baseline 8.80%), with a between-treatment difference of -0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was -1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between-treatment difference: -0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain.

conclusionsVildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%.

Indexed as

AdamantaneAdolescentAdultAgedAged, 80 and overBlood GlucoseBody WeightDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaAdamantaneBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminNitrilesPyrrolidinesSulfonylurea CompoundsVildagliptinDPP-4 inhibitorglimepiridemetforminoral antidiabetic drugtype 2 diabetesvildagliptin

Identifiers

PMID24199686
PMCPMC4237555
OpenAlexW2041445139

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.