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: OBJECTIVE
  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 ≤ 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.
  
  
  RESULTS
  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.
  
  
  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.
authors: Thyroid Unit and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors: G H
authors: GH
authors: Daniels
authors: L
authors: L
authors: Hegedüs
authors: S P
authors: SP
authors: Marso
authors: M A
authors: MA
authors: Nauck
authors: B
authors: B
authors: Zinman
authors: R M
authors: RM
authors: Bergenstal
authors: J F E
authors: JF
authors: Mann
authors: J
authors: J
authors: Derving Karsbøl
authors: A C
authors: AC
authors: Moses
authors: J B
authors: JB
authors: Buse
authors: R M
authors: RM
authors: Tuttle
mesh_terms: D000368:Aged; D015992:Body Mass Index; D002116:Calcitonin / Q000097:blood*; D002318:Cardiovascular Diseases / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D016014:Linear Models; D000069450:Liraglutide / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012737:Sex Factors
chemical_list: D007004:Hypoglycemic Agents; D000069450:Liraglutide; D002116:Calcitonin
keywords: c-cell disease; calcitonin; diabetes; incretins
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