LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial

William M Steinberg, Michael A Nauck, Bernard Zinman, Gilbert H Daniels, Richard M Bergenstal, Johannes F E Mann, Lasse Steen Ravn, Alan C Moses, Mette Stockner, Florian M M Baeres, Steven P Marso, John B Buse, LEADER Trial investigators, William M Steinberg, Michael A Nauck, Bernard Zinman, Gilbert H Daniels, Richard M Bergenstal, Johannes F E Mann, Lasse Steen Ravn, Alan C Moses, Mette Stockner, Florian M M Baeres, Steven P Marso, John B Buse, LEADER Trial investigators

Abstract

Objectives: 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.

Trial registration: ClinicalTrials.gov NCT01179048.

Figures

FIGURE 1
FIGURE 1
Distribution of (A) lipase and (B) amylase values in all randomized subjects. Horizontal lines (from lowest to highest value on y-axis) denote 1, 2, 3, and 10 times ULN values.

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