Trial reportDiabetic medicine : a journal of the British Diabetic Association2014

Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study.

M Bajaj, R Gilman, S Patel, J Kempthorne-Rawson, D Lewis-D'Agostino, H-J Woerle

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2014. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. Cited by 18 papers, 4 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
18citing papers in PubMed, 4 pooled it
6.4field-weighted citation impact, top 3% 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 comparatorfavours the treatment →
21 · no effect
Glycemic controlfavours the treatment · against placebo · t2d, obesityfeeds one cell of the map
OR 2.94P = 0.0033
In patients with baseline HbA1c ≥ 53 mmol/mol (7.0%), 32.4% of patients in the linagliptin group and 13.8% in the placebo group achieved HbA1c < 53 mmol/mol (7.0%) (odds ratio 2.94; P = 0.0033).

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 comparatorfavours the treatment →
1 · no effect
This paper · 2014
OR 2.94
NCT01340768870 enrolled · 2010
RR 0.520.29 to 0.94
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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. DPP-4 Inhibition and the Path to Clinical Proof.Frontiers in endocrinology · 2019
    Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Combination of linagliptin and metformin for the treatment of patients with type 2 diabetes.Clinical medicine insights. Endocrinology and diabetes · 2015
    Review
  16. The clinical application of linagliptin in Asians.Therapeutics and clinical risk management · 2015
    Review
  17. Review
  18. 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

6 authors at 5 institutions in 3 countries.

M BajajBaylor College of Medicine, Houston, TX.
R Gilman
S Patel
J Kempthorne-Rawson
D Lewis-D'Agostino
H-J Woerle
Boehringer Ingelheim (United States) · USBaylor College of Medicine · USBoehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United Kingdom) · GBData Harbor (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.

aimsTo investigate the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in patients with Type 2 diabetes mellitus inadequately controlled by a combination of metformin and pioglitazone.

methodsThis was a multi-centre, phase 3, randomized, double-blind, placebo-controlled study comparing linagliptin 5 mg once daily (n = 183) and placebo (n = 89) as add-on to metformin and pioglitazone. The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c ) after 24 weeks.

resultsThe placebo-corrected adjusted mean (se) change in HbA1c from baseline to 24 weeks was -6 (1) mmol/mol [-0.57 (0.13)%] (P < 0.0001). In patients with baseline HbA1c ≥ 53 mmol/mol (7.0%), 32.4% of patients in the linagliptin group and 13.8% in the placebo group achieved HbA1c < 53 mmol/mol (7.0%) (odds ratio 2.94; P = 0.0033). The placebo-corrected adjusted mean (se) change from baseline in fasting plasma glucose at week 24 was -0.57 (0.26) mmol/l [-10.4 (4.7) mg/dl] (P = 0.0280). The incidence of serious adverse events was 2.2% with linagliptin and 3.4% with placebo. Investigator-defined hypoglycaemia occurred in 5.5% of the linagliptin group and 5.6% of the placebo group. No meaningful changes in mean body weight were noted for either group.

conclusionsLinagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control, without an additional risk of hypoglycaemia or weight gain (Clinical Trials Registry No: NCT 00996658).

Indexed as

AdultAgedBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsLinagliptinMaleMetforminMiddle AgedPioglitazoneBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLinagliptinMetforminPioglitazonePurinesQuinazolinesThiazolidinediones

Identifiers

PMID24824197
PMCPMC4257097
OpenAlexW2006925617

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.