Evidence map›Paper›PMID 21781152›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2011

Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study.

D R Owens, R Swallow, K A Dugi, H J Woerle

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02613897 (A 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy), which is not on this map. Cited by 82 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 12 pooled it
21.9field-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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · 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.

NCT02613897 nacompletedstarted 2016, after this paper: background citation

A 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy

Ran2016Enrolled56Registered outcomes9Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsdapagliflozin, Placebo, Saxagliptin
PMID 24463448PMID 9742977PMID 18726829PMID 25425451PMID 21114605PMID 24947443PMID 17244786PMID 15277443PMID 15549021PMID 17613449PMID 17876024PMID 17934153other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

82 citing papers in PubMed, 12 syntheses or guidelines pooled it, 213 citations in OpenAlex.

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22 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 3 countries.

D R OwensUniversity Hospital Llandough, Cardiff, UK.
R Swallow
K A Dugi
H J Woerle
Boehringer Ingelheim (Egypt) · EGBoehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United Kingdom) · GBUniversity Hospital Llandough · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo examine the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in persons with Type 2 diabetes mellitus inadequately controlled [HbA(1c) 53-86 mmol/mol (7.0-10.0%)] by metformin and sulphonylurea combination treatment.

methodsA multi-centre, 24-week, randomized, double-blind, parallel-group study in 1058 patients comparing linagliptin (5 mg once daily) and placebo when added to metformin plus sulphonylurea. The primary endpoint was the change in HbA(1c) after 24 weeks.

resultsAt week 24, the linagliptin placebo-corrected HbA(1c) adjusted mean change from baseline was -7 mmol/mol (-0.62%) [95% CI -8 to -6 mmol/mol (-0.73 to -0.50%); P < 0.0001]. More participants with baseline HbA(1c) ≥ 53 mmol/mol (≥ 7.0%) achieved an HbA(1c) < 53 mmol/mol (<7.0%) with linagliptin compared with placebo (29.2% vs. 8.1%, P< 0.0001). Fasting plasma glucose was reduced with linagliptin relative to placebo (-0.7 mmol/l, 95% CI -1.0 to -0.4; P<0.0001). Improvements in homeostasis model assessment of β-cell function were seen with linagliptin (P<0.001). The proportion of patients who reported a severe adverse event was low in both groups (linagliptin 2.4%; placebo 1.5%). Symptomatic hypoglycaemia occurred in 16.7 and 10.3% of the linagliptin and placebo groups, respectively. Hypoglycaemia was generally mild or moderate; severe hypoglycaemia was reported in 2.7 and 4.8% of the participants experiencing hypoglycaemic episodes in the linagliptin and placebo groups, respectively. No significant weight changes were noted.

conclusionsIn patients with Type 2 diabetes, adding linagliptin to metformin given in combination with a sulphonylurea significantly improved glycaemic control and this was well tolerated. Linagliptin could provide a valuable treatment option for individuals with inadequate glycaemic control despite ongoing combination therapy with metformin and a sulphonylurea.

Indexed as

AdolescentAdultAgedAged, 80 and overBiomarkersBlood GlucoseBody Mass IndexDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Therapy, CombinationFastingFemaleGlycated HemoglobinHumansHypoglycemic AgentsBiomarkersBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLinagliptinMetforminPurinesQuinazolinesSulfonylurea Compounds

Identifiers

PMID21781152
OpenAlexW1911149840

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.