Trial reportJournal of diabetes and its complications

Efficacy and safety of linagliptin in subjects with type 2 diabetes mellitus and poor glycemic control: pooled analysis of data from three placebo-controlled phase III trials.

Stefano Del Prato, Marja-Riitta Taskinen, David R Owens, Maximilian von Eynatten, Angela Emser, Yan Gong, Silvia Chiavetta, Sanjay Patel, Hans-Juergen Woerle

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of diabetes and its complications. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It reports registered trial NCT03004612. Cited by 9 papers, 2 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
9citing papers in PubMed, 2 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 →
-1.700 · no effect
Glycemic controlfavours the treatment · against placebo · t2d, ckdfeeds one cell of the map
Δ -1.10-1.70 to -0.50
Linagliptin significantly lowered fasting plasma glucose levels vs. placebo (1.6 mmol/l vs. 0.4 mmol/l); treatment difference, 1.1 mmol/l (95% CI, -1.7 to -0.5).

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
Δ -1.10-1.70 to -0.50
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.

NCT03004612 phase4completed

Effect of Linagliptin + Metformin vs Metformin Alone on the Role of Pancreatic Islet Function, Insulin Resistance and Markers of Cardiovascular Risk in Patients With Prediabetes: Randomized Clinical Trial

Ran2016Enrolled144Registered outcomes5Posted comparisons0ConditionsInsulin Resistance, Prediabetic StateArmsLinagliptin + metformin, Metformin
Open the trial in the graph
NCT04542213 phase3completednot on this map

Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19

TypeinterventionalSponsorHospital Regional de Alta Especialidad del BajioRan2020 to 2021Enrolled70ConditionsHyperglycemia, Covid19ArmsLinagliptin tablet, Insulin
5 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. 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

9 authors.

Stefano Del PratoDepartment of Endocrinology and Metabolism, Section of Diabetes, University of Pisa, Pisa, Italy. stefano.delprato@med.unipi.it
Marja-Riitta Taskinen
David R Owens
Maximilian von Eynatten
Angela Emser
Yan Gong
Silvia Chiavetta
Sanjay Patel
Hans-Juergen Woerle

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 evaluate the efficacy/safety of dipeptidyl peptidase-4 inhibitor, linagliptin, in subjects with insufficiently controlled type 2 diabetes mellitus (T2DM), and factors influencing treatment response.

methodsPooled analysis of data from 2258 subjects in three 24-week phase III, randomized, placebo-controlled, parallel-group studies, who received oral linagliptin (5 mg/day) or placebo as monotherapy, added-on to metformin, or added-on to metformin plus sulfonylurea was performed.

resultsAmong 388 subjects with HbA1c ≥9.0%, adjusted mean baseline HbA1c (9.4% both groups) declined to 8.3% in linagliptin group and 9.1% in placebo group at 24 weeks (P<.0001) and adjusted mean change from baseline was 1.2% (vs. 0.4%, placebo). Linagliptin significantly lowered fasting plasma glucose levels vs. placebo (1.6 mmol/l vs. 0.4 mmol/l); treatment difference, 1.1 mmol/l (95% CI, -1.7 to -0.5). Treatment and washout of previous oral antidiabetes drugs were the only factors to independently affect HbA1c change at week 24. Adverse event rates were similar for linagliptin (61.9%) and placebo (62.7%). Hypoglycemia was rare with linagliptin monotherapy/add-on to metformin (≤1%) and increased when linagliptin was added to metformin plus sulfonylurea (linagliptin, 17.9% vs. placebo, 8.3%).

conclusionsLinagliptin was an effective, well-tolerated treatment in subjects with T2DM and insufficient glycemic control, both as monotherapy or added-on to metformin/metformin plus sulfonylurea.

Indexed as

AgedDiabetes Mellitus, Type 2Diabetic NephropathiesDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug ResistanceDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsIncidenceKidneyLinagliptinDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLinagliptinMetforminPurinesQuinazolinesSulfonylurea Compounds

Identifiers

What Socratic holds

Texttitle and abstract
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.