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
NCT ID: NCT02370537
Last Updated: 2017-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
490 participants
INTERVENTIONAL
2015-03-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Epanova® (omega-3 carboxylic acids)
4 g (administered orally as 4 x 1 g capsules)
Omacor® (omega-3-acid ethyl esters)
4 g (administered orally as 4 x 1 g capsules)
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.
Epanova® (omega-3 carboxylic acids)
4 g (administered orally as 4 x 1 g capsules)
Omacor® (omega-3-acid ethyl esters)
4 g (administered orally as 4 x 1 g capsules)
Interventions
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Epanova® (omega-3 carboxylic acids)
4 g (administered orally as 4 x 1 g capsules)
Omacor® (omega-3-acid ethyl esters)
4 g (administered orally as 4 x 1 g capsules)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed Type 2 diabetics (American Diabetes Association guidelines;), on oral antibiotic drug use ≥3 months and HbA1c value ≥6.5% and ≤9.0% at Visit 1.
* Have a body mass index ≥18 kg/m2 and ≤40 kg/m2 and weigh at least 50 kg.
Exclusion Criteria
* On insulin therapy or treated with injectable Glucagon-like peptide-1 (GLP-1).
* Treated with bile acid sequestrants.
* Serum levels of TGs \>10 mmol/L at any time during the study.
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Aarhus, , Denmark
Research Site
Frederiksberg, , Denmark
Research Site
København NV, , Denmark
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Létavértes, , Hungary
Research Site
Daugavpils, , Latvia
Research Site
Jēkabpils, , Latvia
Research Site
Riga, , Latvia
Research Site
Bialystok, , Poland
Research Site
Puławy, , Poland
Research Site
Staszów, , Poland
Research Site
Zamość, , Poland
Research Site
Bardejov, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Ľubochňa, , Slovakia
Research Site
Gothenburg, , Sweden
Research Site
Linköping, , Sweden
Research Site
Lund, , Sweden
Research Site
Malmo, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Uppsala, , Sweden
Countries
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References
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Lindkvist B, Nilsson C, Kvarnstrom M, Oscarsson J. Importance of pancreatic exocrine dysfunction in patients with type 2 diabetes: A randomized crossover study. Pancreatology. 2018 Jul;18(5):550-558. doi: 10.1016/j.pan.2018.05.483. Epub 2018 May 19.
Other Identifiers
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2014-003511-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5881C00006
Identifier Type: -
Identifier Source: org_study_id
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