CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 490 enrolled
Drug / intervention
Epanova® (omega-3 carboxylic acids) +1 moredrug
Likely dose
Epanova® (omega-3 carboxylic acids) 4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02370537
NCT02370537Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Feb 25, 2015·Updated Jan 20, 2017

In Brief

A Phase 2 clinical trial evaluating Epanova® (omega-3 carboxylic acids) and Omacor® (omega-3-acid ethyl esters) for Diabetes Mellitus, Type 2 and Exocrine Pancreatic Insufficiency. Completed, enrolled 490 participants across 22 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
CountriesDenmark, Hungary, Latvia, Poland, Slovakia, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 25, 2015
Enrollment StartMar 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.4 years ago

Interventions

Epanova® (omega-3 carboxylic acids)drug

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

Omacor® (omega-3-acid ethyl esters)drug

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