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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02370537
Other study ID # D5881C00006
Secondary ID 2014-003511-11
Status Completed
Phase Phase 2
First received February 24, 2015
Last updated November 30, 2015
Start date March 2015
Est. completion date November 2015

Study information

Verified date November 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 491
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

Country Name City State
Denmark Research Site Århus
Denmark Research Site Frederiksberg
Denmark Research Site København NV
Hungary Research Site Balatonfüred
Hungary Research Site Budapest
Hungary Research Site Létavértes
Latvia Research Site Daugavpils
Latvia Research Site Jekabpils
Latvia Research Site Riga
Poland Research Site Bialystok
Poland Research Site Pulawy
Poland Research Site Staszów
Poland Research Site Zamosc
Slovakia Research Site Bardejov
Slovakia Research Site Bratislava
Slovakia Research Site Lubochna
Sweden Research Site Göteborg
Sweden Research Site Linköping
Sweden Research Site Lund
Sweden Research Site Malmo
Sweden Research Site Stockholm
Sweden Research Site Uppsala

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Hungary,  Latvia,  Poland,  Slovakia,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Serum triglyceride (TG) level For Part A, the distribution of serum TG levels by the degree of PEI will be summarized. 7 days No
Primary Part B: PK of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) by assessment of AUC0-t Baseline-corrected area under plasma concentration time curve from time 0 to the last measurable concentration (AUC0-t) will be measured for the sum of DHA+EPA, and EPA and DHA separately. 48 hours No
Primary Part B: PK of DHA and EPA by assessment of AUC Area under plasma concentration-time curve from zero to infinity (AUC) will be measured for the sum of DHA+EPA, and EPA and DHA separately. 48 hours No
Primary Part B: PK of DHA and EPA by assessment of Cmax Maximum plasma drug concentration (Cmax) will be measured for the sum of DHA+EPA, and EPA and DHA separately. 48 hours No
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