Trials / Completed
CompletedNCT02370537
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 490 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2015-02-25
- Last updated
- 2017-01-20
- Results posted
- 2017-01-20
Locations
22 sites across 6 countries: Denmark, Hungary, Latvia, Poland, Slovakia, Sweden
Source: ClinicalTrials.gov record NCT02370537. Inclusion in this directory is not an endorsement.