A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients with Type 2 Diabetes and also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients wit...

Update Il y a 4 ans
Reference: EUCTR2014-003511-11

A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients with Type 2 Diabetes and also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients with Different Degrees of PEI

Woman and Man

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Extract

The primary objective of Part A of the trial is to describe the distribution of plasma triglycerides in patients with Type 2 Diabetes Mellitus by degree of pancreatic exocrine insufficiency (Normal: faecal elastase-1 concentration [FEC] ≥200 μg/g; Intermediate: FEC ≥100 μg/g to <200 μg/g; and Low: FEC <100 μg/g). The primary objective of Part B of the trial is to evaluate and compare the plasma exposure of docosahexaenoic acid and eicosapentaenoic acid from EPANOVA® and OMACOR®, respectively, in patients with Type 2 Diabetes Mellitus with different levels of FEC.


Inclusion criteria

  • Type 2 Diabetes