Clinical trial NCT02370537: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Exocrine Pancreatic Insufficiency
Keywords: omega-3 carboxylic acid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥18 years and ≤70 years, with suitable veins for cannulation or repeated venipuncture.
* 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:

* Intolerance to Omega-3 fatty acids, ethyl esters or fish.
* 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.

Primary outcomes:
measure: Part A: Serum TG Level.
timeFrame: 7 days after enrollment.
measure: Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®.
timeFrame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.
measure: Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.
timeFrame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.
measure: Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
timeFrame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.
measure: Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.
timeFrame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.
measure: Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.
timeFrame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.
measure: Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
timeFrame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Research Site
city: København NV
country: Denmark
facility: Research Site
city: Århus
country: Denmark
facility: Research Site
city: Balatonfüred
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Létavértes
country: Hungary
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Jekabpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Puławy
country: Poland
facility: Research Site
city: Staszów
country: Poland
facility: Research Site
city: Zamość
country: Poland
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Lubochna
country: Slovakia
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
References:
citation: 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.