title: LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial.
abstract: OBJECTIVE
  This report from the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial describes baseline lipase and amylase activity in type 2 diabetic subjects without acute pancreatitis symptoms before randomization to the glucagonlike peptide analog liraglutide or placebo.
  
  
  METHODS
  The LEADER is an international randomized placebo-controlled trial evaluating the cardiovascular safety of liraglutide in 9340 type 2 diabetic patients at high cardiovascular risk. Fasting lipase and amylase activity was assessed at baseline, before receiving liraglutide or placebo, using a commercial assay (Roche) with upper limit of normal values of 63 U/L for lipase and 100 U/L for amylase.
  
  
  RESULTS
  Either or both enzymes were above the upper limit of normal in 22.7% of subjects; 16.6% (n = 1540) had an elevated lipase level (including 1.2% >3-fold elevated), and 11.8% (n = 1094) had an elevated amylase level (including 0.2% >3-fold elevated). In multivariable regression models, severely reduced kidney function was associated with the largest effect on increasing activity of both. However, even among subjects with normal kidney function, 12.2% and 7.7% had elevated lipase and amylase levels.
  
  
  CONCLUSIONS
  In this large study of type 2 diabetic patients, nearly 25% had elevated lipase or amylase levels without symptoms of acute pancreatitis. The clinician must take these data into account when evaluating abdominal symptoms in type 2 diabetic patients.
authors.affiliation: From the *Department of Medicine, George Washington University Medical Center, Rockville, MD; †Department of Internal Medicine/Diabetology, Diabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz, Germany; ‡Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada; §Thyroid Unit and Department of Medicine, Massachusetts General Hospital Harvard Medical School, Boston, MA; ║Park Nicollet Institute for Research and Education, International Diabetes Center, Minneapolis, MN; ¶Department of Medicine, Friedrich Alexander University of Erlangen, Erlangen, Germany; #Novo Nordisk, A/S, Bagsvaerd, Denmark; **Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern, Dallas, TX; and ††Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: William M
authors.initials: WM
authors.lastname: Steinberg
authors.forename: Michael A
authors.initials: MA
authors.lastname: Nauck
authors.forename: Bernard
authors.initials: B
authors.lastname: Zinman
authors.forename: Gilbert H
authors.initials: GH
authors.lastname: Daniels
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
authors.forename: Johannes F E
authors.initials: JF
authors.lastname: Mann
authors.forename: Lasse
authors.initials: L
authors.lastname: Steen Ravn
authors.forename: Alan C
authors.initials: AC
authors.lastname: Moses
authors.forename: Mette
authors.initials: M
authors.lastname: Stockner
authors.forename: Florian M M
authors.initials: FM
authors.lastname: Baeres
authors.forename: Steven P
authors.initials: SP
authors.lastname: Marso
authors.forename: John B
authors.initials: JB
authors.lastname: Buse
mesh_terms: D000208:Acute Disease; D000368:Aged; D000681:Amylases / Q000097:blood*; D015415:Biomarkers; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy / Q000201:enzymology*; D004311:Double-Blind Method; D005215:Fasting / Q000097:blood; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D007668:Kidney / Q000503:physiopathology; D008049:Lipase / Q000097:blood*; D000069450:Liraglutide; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced / Q000209:etiology / Q000517:prevention & control
chemical_list: D015415:Biomarkers; D007004:Hypoglycemic Agents; D000069450:Liraglutide; D052216:Glucagon-Like Peptide 1; D008049:Lipase; D000681:Amylases