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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02370537
• Date of registration: 24/02/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: 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
• Date of first enrolment: March 2015
• Target sample size: 490
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02370537
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Denmark, Hungary, Latvia, Poland, Slovakia, Sweden

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Exocrine Pancreatic Insufficiency

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Epanova® (omega-3 carboxylic acids)

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

Primary Outcome(s)

Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®. [Time Frame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.]

Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®. [Time Frame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.]

Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®. [Time Frame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.]

Part A: Serum TG Level. [Time Frame: 7 days after enrollment.]

Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®. [Time Frame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.]

Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®. [Time Frame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.]

Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®. [Time Frame: Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.]

Secondary ID(s)

D5881C00006

2014-003511-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02370537