A Two-part, Open-label, Randomised, Crossover, Multicentre, Phase II Study to Investigate the Presence of Pancreatic Exocrine Insufficiency (PEI) in Patients with Type 2 Diabetes Mellitus, and to Investigate the Pharmacokinetics of EPANOVA and OMACOR Following a Single Oral Dose in Patients with Different Degrees of PEI

Trial Profile

A Two-part, Open-label, Randomised, Crossover, Multicentre, Phase II Study to Investigate the Presence of Pancreatic Exocrine Insufficiency (PEI) in Patients with Type 2 Diabetes Mellitus, and to Investigate the Pharmacokinetics of EPANOVA and OMACOR Following a Single Oral Dose in Patients with Different Degrees of PEI

Completed
Phase of Trial: Phase II

Latest Information Update: 09 May 2017

At a glance

  • Drugs Omega-3 carboxylic acids (Primary) ; Omega-3-acid ethyl esters
  • Indications Hypertriglyceridaemia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Acronyms PRECISE
  • Sponsors AstraZeneca
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 09 May 2017 Results assessing association between faecal elastase-1 concentrations and gastrointestinal symptoms, plasma nutritional markers, and uptake of Epanova versus Omacor, presented at the Digestive Disease Week 2017.
    • 01 Dec 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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