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), 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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence AB A single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 7. | Drug: Epanova® (omega-3 carboxylic acids) 4 g (administered orally as 4 x 1 g capsules) Other Name: omega-3 carboxylic acids Drug: Omacor® (omega-3-acid ethyl esters) 4 g (administered orally as 4 x 1 g capsules) Other Name: omega-3-acid ethyl esters |
| Experimental: Sequence BA A single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 7. | Drug: Epanova® (omega-3 carboxylic acids) 4 g (administered orally as 4 x 1 g capsules) Other Name: omega-3 carboxylic acids Drug: Omacor® (omega-3-acid ethyl esters) 4 g (administered orally as 4 x 1 g capsules) Other Name: omega-3-acid ethyl esters |
