Conditions: Diabetes Mellitus, Type 2 Exocrine Pancreatic Insufficiency
Keywords: omega-3 carboxylic acid
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 490
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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 2: 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.

Interventions: intervention 1: Epanova® (omega-3 carboxylic acids) intervention 2: Omacor® (omega-3-acid ethyl esters)
Intervention descriptions: intervention 1: 4 g (administered orally as 4 x 1 g capsules) intervention 2: 4 g (administered orally as 4 x 1 g capsules)

Protocol document: