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

Identifieur interne : 000889 ( PubMed/Checkpoint ); précédent : 000888; suivant : 000890

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

Auteurs : Per-Henrik Groop [Finlande] ; Mark E. Cooper [Australie] ; Vlado Perkovic [Australie] ; Berthold Hocher [Allemagne] ; Keizo Kanasaki [Japon] ; Masakazu Haneda [Japon] ; Guntram Schernthaner [Autriche] ; Kumar Sharma [États-Unis] ; Robert C. Stanton [États-Unis] ; Robert Toto [États-Unis] ; Jessica Cescutti [France] ; Maud Gordat [France] ; Thomas Meinicke [Allemagne] ; Audrey Koitka-Weber [Allemagne] ; Sandra Thiemann [Allemagne] ; Maximilian Von Eynatten [Allemagne]

Source :

RBID : pubmed:28636754

Abstract

The 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.

DOI: 10.1111/dom.13041
PubMed: 28636754


Affiliations:


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pubmed:28636754

Le document en format XML

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<div type="abstract" xml:lang="en">The 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.</div>
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<Abstract>
<AbstractText Label="AIMS" NlmCategory="OBJECTIVE">The 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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">A 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(2) and urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g despite single agent renin-angiotensin-system blockade were randomized to double-blind linagliptin (n = 182) or placebo (n = 178) for 24 weeks. The primary and key secondary endpoints were change from baseline in HbA1c at week 24 and time-weighted average of percentage change from baseline in UACR over 24 weeks, respectively.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Baseline 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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In 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.</AbstractText>
<CopyrightInformation>© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</CopyrightInformation>
</Abstract>
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<LastName>Groop</LastName>
<ForeName>Per-Henrik</ForeName>
<Initials>PH</Initials>
<AffiliationInfo>
<Affiliation>Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Abdominal Center Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Baker IDI Heart and Diabetes Institute, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
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<Initials>ME</Initials>
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</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Department of Histology and Embryology, Medical College, Jinan University, Guangzhou, China.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Division of Anticipatory Molecular Food Science and Technology, Medical Research Institute, Kanazawa Medical University, Kanazawa, Japan.</Affiliation>
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</AffiliationInfo>
</Author>
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<ForeName>Kumar</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Department of Medicine, Center for Renal Translational Medicine, University of California, San Diego, California.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Stanton</LastName>
<ForeName>Robert C</ForeName>
<Initials>RC</Initials>
<AffiliationInfo>
<Affiliation>Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Toto</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.</Affiliation>
</AffiliationInfo>
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<LastName>Cescutti</LastName>
<ForeName>Jessica</ForeName>
<Initials>J</Initials>
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</AffiliationInfo>
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<Initials>M</Initials>
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</AffiliationInfo>
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<LastName>Meinicke</LastName>
<ForeName>Thomas</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
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</AffiliationInfo>
</Author>
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<LastName>Koitka-Weber</LastName>
<ForeName>Audrey</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.</Affiliation>
</AffiliationInfo>
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<LastName>Thiemann</LastName>
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<Affiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.</Affiliation>
</AffiliationInfo>
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<LastName>von Eynatten</LastName>
<ForeName>Maximilian</ForeName>
<Initials>M</Initials>
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</AffiliationInfo>
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<Language>eng</Language>
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<Year>2017</Year>
<Month>07</Month>
<Day>31</Day>
</ArticleDate>
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<MedlineTA>Diabetes Obes Metab</MedlineTA>
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<Keyword MajorTopicYN="N">clinical trial</Keyword>
<Keyword MajorTopicYN="N">diabetic nephropathy</Keyword>
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<name sortKey="Schernthaner, Guntram" sort="Schernthaner, Guntram" uniqKey="Schernthaner G" first="Guntram" last="Schernthaner">Guntram Schernthaner</name>
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<name sortKey="Sharma, Kumar" sort="Sharma, Kumar" uniqKey="Sharma K" first="Kumar" last="Sharma">Kumar Sharma</name>
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