LEADER 2

Baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: Preliminary observations

on behalf of the LEADER trial investigators

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Aims: To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. Methods: The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤50ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥20ng/l. Results: The mean age of participants was 64.3±7.2years, 64.3% were men, and mean the body mass index was 32.5±6.3kg/m2. The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6)ng/l in men and 1.0 (1.0 to >1)ng/l in women. Serum calcitonin was>10ng/l in 14.6% of men and in 0.96% of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20ml/min/1.73m2 decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men. Conclusions: In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations.

Original languageEnglish (US)
Pages (from-to)477-486
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number5
DOIs
StatePublished - May 1 2015

Fingerprint

Calcitonin
Type 2 Diabetes Mellitus
Serum
Glomerular Filtration Rate
Liraglutide
Placebos
Random Allocation
Population
Thyroid Gland
Body Mass Index
Cardiovascular Diseases

Keywords

  • C-cell disease
  • Calcitonin
  • Diabetes
  • Incretins

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

@article{ae9fed02277f4a8f9427636e033fb4db,
title = "LEADER 2: Baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: Preliminary observations",
abstract = "Aims: To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. Methods: The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤50ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥20ng/l. Results: The mean age of participants was 64.3±7.2years, 64.3{\%} were men, and mean the body mass index was 32.5±6.3kg/m2. The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6)ng/l in men and 1.0 (1.0 to >1)ng/l in women. Serum calcitonin was>10ng/l in 14.6{\%} of men and in 0.96{\%} of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20ml/min/1.73m2 decrease in estimated GFR (eGFR) was associated with a 14{\%} increase in serum calcitonin in women and an 11{\%} increase in men. Conclusions: In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations.",
keywords = "C-cell disease, Calcitonin, Diabetes, Incretins",
author = "{on behalf of the LEADER trial investigators} and Daniels, {G. H.} and L. Heged{\"u}s and Marso, {S. P.} and Nauck, {M. A.} and B. Zinman and Bergenstal, {R. M.} and Mann, {J. F E} and {Derving Karsb{\o}l}, J. and Moses, {A. C.} and Buse, {J. B.} and Tuttle, {R. M.}",
year = "2015",
month = "5",
day = "1",
doi = "10.1111/dom.12444",
language = "English (US)",
volume = "17",
pages = "477--486",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "5",

}

TY - JOUR

T1 - LEADER 2

T2 - Baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: Preliminary observations

AU - on behalf of the LEADER trial investigators

AU - Daniels, G. H.

AU - Hegedüs, L.

AU - Marso, S. P.

AU - Nauck, M. A.

AU - Zinman, B.

AU - Bergenstal, R. M.

AU - Mann, J. F E

AU - Derving Karsbøl, J.

AU - Moses, A. C.

AU - Buse, J. B.

AU - Tuttle, R. M.

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Aims: To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. Methods: The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤50ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥20ng/l. Results: The mean age of participants was 64.3±7.2years, 64.3% were men, and mean the body mass index was 32.5±6.3kg/m2. The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6)ng/l in men and 1.0 (1.0 to >1)ng/l in women. Serum calcitonin was>10ng/l in 14.6% of men and in 0.96% of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20ml/min/1.73m2 decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men. Conclusions: In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations.

AB - Aims: To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. Methods: The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤50ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥20ng/l. Results: The mean age of participants was 64.3±7.2years, 64.3% were men, and mean the body mass index was 32.5±6.3kg/m2. The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6)ng/l in men and 1.0 (1.0 to >1)ng/l in women. Serum calcitonin was>10ng/l in 14.6% of men and in 0.96% of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20ml/min/1.73m2 decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men. Conclusions: In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations.

KW - C-cell disease

KW - Calcitonin

KW - Diabetes

KW - Incretins

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U2 - 10.1111/dom.12444

DO - 10.1111/dom.12444

M3 - Article

VL - 17

SP - 477

EP - 486

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 5

ER -