MedTrace Logo

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

NCT02370537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2017-01-20

Study results available
· View outcomes & findings →

Summary

This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare Products Ltd) following a single oral dose in patients with different degrees of PEI.

Conditions

  • Diabetes Mellitus, Type 2
  • Exocrine Pancreatic Insufficiency

Interventions

DRUG

Epanova® (omega-3 carboxylic acids)

4 g (administered orally as 4 x 1 g capsules)

DRUG

Omacor® (omega-3-acid ethyl esters)

4 g (administered orally as 4 x 1 g capsules)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Denmark
  • Hungary
  • Latvia
  • Poland
  • Slovakia
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370537 on ClinicalTrials.gov