European Trial to Investigate Exocrine Pancreatic Insufficiency in Patients with Type 2 Diabetes Mellitus

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:

• Arm A will receive 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.
• Arm B will receive 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.

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.