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 - PRECISE

Study identifier:D5881C00006

ClinicalTrials.gov identifier:NCT02370537

EudraCT identifier:2014-003511-11

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 2

Healthy volunteers

No

Study drug

Epanova® (omega-3 carboxylic acids), Epanova® (omega-3 carboxylic acids), Omacor® (omega-3-acid ethyl esters), Omacor® (omega-3-acid ethyl esters)

Sex

All

Actual enrollment

490

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Mar 2015
Primary Completion Date: 01 Nov 2015
Study Completion Date: 01 Nov 2015

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria