Steinberg, William M.Nauck, Michael A.Zinman, BernardDaniels, GilbertBergenstal, Richard M.Mann, Johannes F.E.Steen Ravn, LasseMoses, Alan C.Stockner, MetteBaeres, Florian M.M.Marso, Steven P.Buse, John B.2014-11-032014Steinberg, W. M., M. A. Nauck, B. Zinman, G. H. Daniels, R. M. Bergenstal, J. F. Mann, L. Steen Ravn, et al. 2014. “LEADER 3—Lipase and Amylase Activity in Subjects With Type 2 Diabetes: Baseline Data From Over 9000 Subjects in the LEADER Trial.” Pancreas 43 (8): 1223-1231. doi:10.1097/MPA.0000000000000229. http://dx.doi.org/10.1097/MPA.0000000000000229.0885-3177http://nrs.harvard.edu/urn-3:HUL.InstRepos:13347586Objectives: 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.en-USpancreatitislipaseamylasetype 2 diabetesJournal Article2014-11-0310.1097/MPA.0000000000000229