Multicenter phase II study will also evaluate pharmacokinetics of omega-3 carboxylic acids and omega-3-acid ethyl esters administered to patients with varying degrees of EPI.
AstraZeneca plans to initiate a 2-part open-label, randomized, crossover, multicenter, non-therapeutic phase II study to investigate the presence of exocrine pancreatic insufficiency (EPI) in patients with type 2 diabetes mellitus, and to investigate the pharmacokinetics of Epanova (omega-3 carboxylic acids) and Omacor (omega-3-acid ethyl esters) following a single oral dose in patients with different degrees of EPI.
The official title of the study is “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.”
The study will have an expected enrollment of 66 patients at multiple sites across 5 European countries.
The primary outcome measures will be plasma triglyceride levels (after 7 days of treatment) and pharmacokinetics of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) after 48 hours.
Patients will be randomized to one of two treatment arms:
To be eligible for participation in this study potential patients must be 18-70 years of age, have a confirmed diagnosis of type 2 diabetes mellitus, be on a regimen of oral antibiotics for at least 3 months prior to enrollment, have HbA1c value ≥6.5% and ≤9.0% at baseline, and have a BMI of 18-40.
Patients who are on insulin therapy and/or have been treated with an injectable GLP-1 agonist or bile acid sequestrants are not eligible for this study.