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
Daniels GH, Hegedus L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann J, Karsbol JD, Moses AC, Buse JB, Tuttle M (2015)
Publication Type: Journal article
Publication year: 2015
Journal
Book Volume: 17
Pages Range: 477-86
Journal Issue: 5
DOI: 10.1111/dom.12444
Abstract
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.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 <= 50 ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5 years. 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 >= 20 ng/l.The mean age of participants was 64.3 ± 7.2 years, 64.3% were men, and mean the body mass index was 32.5 ± 6.3 kg/m(2). 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 >10 ng/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 20 ml/min/1.73 m(2) decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men.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.
Involved external institutions
Memorial Sloan Kettering Cancer Center
United States (USA) (US)
University of North Carolina at Chapel Hill
United States (USA) (US)
Novo Nordisk A/S
Denmark (DK)
International Diabetes Center at Park Nicollet (IDC)
United States (USA) (US)
University of Toronto
Canada (CA)
Diabeteszentrum Bad Lauterberg
Germany (DE)
University of Texas Southwestern Medical Center (UT Southwestern)
United States (USA) (US)
University of Southern Denmark / Syddansk Universitet
Denmark (DK)
Harvard University
United States (USA) (US)
United States (USA) (US)
University of North Carolina at Chapel Hill
United States (USA) (US)
Novo Nordisk A/S
Denmark (DK)
International Diabetes Center at Park Nicollet (IDC)
United States (USA) (US)
University of Toronto
Canada (CA)
Diabeteszentrum Bad Lauterberg
Germany (DE)
University of Texas Southwestern Medical Center (UT Southwestern)
United States (USA) (US)
University of Southern Denmark / Syddansk Universitet
Denmark (DK)
Harvard University
United States (USA) (US)
How to cite
APA:
Daniels, G.H., Hegedus, L., Marso, S.P., Nauck, M.A., Zinman, B., Bergenstal, R.M.,... Tuttle, M. (2015). 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. Diabetes Obesity & Metabolism, 17(5), 477-86. https://dx.doi.org/10.1111/dom.12444
MLA:
Daniels, G. H., et al. "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." Diabetes Obesity & Metabolism 17.5 (2015): 477-86.
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