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 (PRECISE)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2; Exocrine Pancreatic Insufficiency

Treatments: Drug: Epanova® (omega-3 carboxylic acids); Drug: Omacor® (omega-3-acid ethyl esters)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02370537

2014-003511-11 (EudraCT Number)

D5881C00006

Details and patient eligibility

About

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.

Enrollment: 490 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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490 participants in 2 patient groups

Sequence AB

Experimental group

Description:

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.

Treatment:

Drug: Omacor® (omega-3-acid ethyl esters)

Drug: Epanova® (omega-3 carboxylic acids)

Sequence BA

Experimental group

Description:

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.

Treatment:

Drug: Omacor® (omega-3-acid ethyl esters)

Drug: Epanova® (omega-3 carboxylic acids)