Phase 2
N=315
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
Diabetes Mellitus, Type 2 · Exocrine Pancreatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02370537 ↗Enrolled (actual)
315
Serious AEs
1.0%
Results posted
Jan 2017
Primary outcome: Primary: Part A: Serum TG Level. — 2.07; 1.68; 2.00 millimole per litre (mmol/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epanova® (omega-3 carboxylic acids) (Drug); Omacor® (omega-3-acid ethyl esters) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Serum TG Level. |
2.07; 1.68; 2.00 | — |
| PRIMARY 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®. |
2170; 1650; 2000; 946; 2070; 1260 | — |
| PRIMARY Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®. |
801; 1040; 719; 567; 625; 810 | — |
| PRIMARY Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®. |
9700; 8780; 8990; 5130; 8890; 6690 | — |
| PRIMARY Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®. |
137; 71.5; 116; 53.9; 131; 69.3 | — |
| PRIMARY Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®. |
59.0; 60.5; 56.0; 51.0; 53.8; 59.7 | — |
| PRIMARY Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®. |
622; 421; 553; 328; 592; 413 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02370537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.