Evidence map›Paper›PMID 28636754›Full record

Trial reportDiabetes, obesity & metabolism2017

Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial.

Per-Henrik Groop, Mark E Cooper, Vlado Perkovic, Berthold Hocher, Keizo Kanasaki, Masakazu Haneda, Guntram Schernthaner, Kumar Sharma, Robert C Stanton, Robert Toto and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01792518 (A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria), which is not on this map. Cited by 75 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 12 pooled it
12.9field-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.

NCT01792518 phase3completednot on this map

A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)

TypeinterventionalSponsorBoehringer IngelheimRan2013 to 2015Enrolled360ConditionsDiabetes Mellitus, Type 2ArmsPlacebo, Linagliptin 5mg
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 12 syntheses or guidelines pooled it, 149 citations in OpenAlex.

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  17. Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease.Clinical journal of the American Society of Nephrology : CJASN · 2020
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15 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 8 countries.

Per-Henrik GroopFolkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland.
Mark E CooperBaker IDI Heart and Diabetes Institute, Melbourne, Australia.
Vlado PerkovicThe George Institute for Global Health, Faculty of Medicine, University of Sydney, Sydney, Australia.
Berthold HocherInstitute of Nutritional Science, University of Potsdam, Potsdam, Germany.
Keizo KanasakiDepartment of Diabetology and Endocrinology, Kanazawa Medical University, Kanazawa, Japan.
Masakazu HanedaDivision of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.
Guntram SchernthanerDepartment of Internal Medicine, Rudolfstiftung Hospital, Vienna, Austria.
Kumar SharmaDepartment of Medicine, Center for Renal Translational Medicine, University of California, San Diego, California.
Robert C StantonJoslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.
Robert TotoDepartment of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
Jessica CescuttiBoehringer Ingelheim France S.A.S, Reims, France.
Maud GordatBoehringer Ingelheim France S.A.S, Reims, France.
Thomas MeinickeBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Audrey Koitka-WeberBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Sandra ThiemannBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Maximilian von EynattenBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (France) · FRAsahikawa Medical University · JPBaker Heart and Diabetes Institute · AUHarvard University · USHelsinki University Hospital · FIJinan University · CNKanazawa Medical University · JPRudolfinerhaus Hospital · ATThe George Institute for Global Health · AUThe University of Texas Southwestern Medical Center · USUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe MARLINA-T2D study (ClinicalTrials.gov, NCT01792518) was designed to investigate the glycaemic and renal effects of linagliptin added to standard-of-care in individuals with type 2 diabetes and albuminuria.

methodsA total of 360 individuals with type 2 diabetes, HbA1c 6.5% to 10.0% (48-86 mmol/mol), estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m

resultsBaseline mean HbA1c and geometric mean (gMean) UACR were 7.8% ± 0.9% (62.2 ± 9.6 mmol/mol) and 126 mg/g, respectively; 73.7% and 20.3% of participants had microalbuminuria or macroalbuminuria, respectively. After 24 weeks, the placebo-adjusted mean change in HbA1c from baseline was -0.60% (-6.6 mmol/mol) (95% confidence interval [CI], -0.78 to -0.43 [-8.5 to -4.7 mmol/mol]; P < .0001). The placebo-adjusted gMean for time-weighted average of percentage change in UACR from baseline was -6.0% (95% CI, -15.0 to 3.0; P = .1954). The adverse-event profile, including renal safety and change in eGFR, was similar between the linagliptin and placebo groups.

conclusionsIn individuals at early stages of diabetic kidney disease, linagliptin significantly improved glycaemic control but did not significantly lower albuminuria. There was no significant change in placebo-adjusted eGFR. Detection of clinically relevant renal effects of linagliptin may require longer treatment, as its main experimental effects in animal studies have been to reduce interstitial fibrosis rather than alter glomerular haemodynamics.

Indexed as

AgedAlbuminuriaBlood GlucoseDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodFemaleHumansHyperglycemiaLinagliptinMaleMiddle AgedRenal InsufficiencyStandard of CareTreatment OutcomeBlood GlucoseLinagliptinantidiabetic drugclinical trialdiabetic nephropathyDPP-IV inhibitorglycaemic controllinagliptin

Identifiers

PMID28636754
PMCPMC5655723
OpenAlexW2639738157

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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.