Pancreatin therapy in patients with insulin‐treated diabetes mellitus and exocrine pancreatic insufficiency according to low fecal elastase 1 concentrations. Results of a prospective multi‐centre trial

Abstract

Background Recently, high prevalence of exocrine dysfunction in diabetic populations has been reported. Patients with fecal elastase 1 concentration (FEC) ®) (39 patients) or placebo (41 patients) in a double‐blind manner. Parameters of glucose metabolism, diabetes therapy and clinical symptoms were recorded in standardized protocols for 16 weeks. Results During the observation phase of 16 weeks, there were no significant differences between both groups concerning HbA_1c, fasting glucose levels, 2‐h pp glucose levels, clinical parameters and safety parameters. A reduction in mild and moderate hypoglycemia was observed in the pancreatin group at the end of the study. Conclusions Pancreatin therapy can be used safely in patients with diabetes mellitus and exocrine dysfunction. Parameters of glucose metabolism were not improved by enzyme replacement therapy. Copyright © 2007 John Wiley & Sons, Ltd.