title: Increased variability and abnormalities in pancreatic enzyme concentrations in otherwise asymptomatic subjects with type 2 diabetes.
abstract: BACKGROUND
  Recent studies have demonstrated an increased incidence of pancreatitis in patients with type 2 diabetes compared with obese nondiabetic individuals. Serum lipase and pancreatic amylase concentrations are used in conjunction with clinical findings to diagnose pancreatitis.
  
  
  METHODS
  In two large clinical trials of overweight/obese nondiabetic and type 2 diabetic subjects, lipase and pancreatic amylase were measured at screening and 2-5 weeks later at baseline (prior to treatment with study medication).
  
  
  RESULTS
  Lipase and pancreatic amylase concentrations were above the upper limit of normal (ULN) in 13% and 6% of type 2 diabetic subjects, respectively, and were approximately three-fold (3 ×) higher than the proportion of nondiabetic subjects with levels above ULN. Elevations exceeding ULN were seen in many subjects asymptomatic for pancreatitis; however, elevations >2 × ULN and >3 × ULN were uncommon, and elevations >3 × ULN were often associated with a history of dyslipidemia, hyperlipidemia, and gastrointestinal disorders. Additionally, enzyme concentrations varied within this 2-5-week screening period, including shifts between elevated and normal levels.
  
  
  CONCLUSIONS
  Results from this post hoc analysis suggest that, although pancreatic enzymes can be a useful marker for pancreatitis within the proper clinical context, diagnosis of pancreatitis may be confounded in populations known to have asymptomatic elevations associated with disease, such as type 2 diabetes. Further effort is needed to clarify the etiology and epidemiology of pancreatic enzyme elevations in type 2 diabetes.
authors.affiliation: Amylin Pharmaceuticals LLC, San Diego, CA, USA.
authors.forename: Jaret
authors.initials: J
authors.lastname: Malloy
authors.forename: Kate
authors.initials: K
authors.lastname: Gurney
authors.forename: Kevin
authors.initials: K
authors.lastname: Shan
authors.forename: Ping
authors.initials: P
authors.lastname: Yan
authors.forename: Steve
authors.initials: S
authors.lastname: Chen