EUCTR2014-003511-11-SEActive, not recruitingNot Applicable
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 - PRECISE
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female aged =18 years and =70 years, with suitable veins for cannulation or repeated venipuncture.
- •2. Clinically diagnosed Type 2 diabetics (American Diabetes Association guidelines; American Diabetes Association 2014), on oral antidiabetic drug use =3 months and HbA1c value =6.5% and =9.0% at Visit 1.
- •3. Have a body mass index =18 kg/m2 and =40 kg/m2 and weigh at least 50 kg.
- •4. Be willing to maintain current activity level.
- •5. For patients on treatment for hypertriglyceridaemia: be willing to stop treatment with fibrates, niacin and Omega-3 at Visit 1 and for the duration of the entire study.
- •6. Be willing to adhere to the total fat intake recommended by the Therapeutic Lifestyle Changes diet during screening and washout periods.
- •7. Be willing to avoid consuming fish, seafood and fish products from Visit 2 and for the remainder of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •1. History of, or presence of (as found at Visit 1) any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the study.
- •2. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of IP.
- •3. Intolerance to Omega-3 fatty acids, ethyl esters or fish.
- •4. On insulin therapy or treated with injectable glucagon-like peptide-1.
- •5. Treated with bile acid sequestrants.
- •6. Use of fish oil, other eicosapentaenoic acid or docosahexaenoic acid-containing supplements, or eicosapentaenoic acid and/or docosahexaenoic acid-fortified foods within 4 weeks of Visit 2, or during the study.
- •7. Use of flaxseed, perilla seed, hemp, spirulina, or blackcurrant oils within 7 days of Visit 2, and during the remainder of the study.
- •8. Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator, found at Visit 1.
- •9. Plasma levels of triglycerides >10 mmol/L at any time during the study:
- •- Plasma levels of triglycerides will be checked at enrolment (Visit 2). Results should be available prior to any further study-related procedures being performed.
- •10. Smokers who cannot abstain from smoking during the clinic visits.
- •11. Recent history (past 12 months) of drug abuse or alcohol abuse, as judged by the Investigator.
- •12. Women who are pregnant, lactating, or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is <1 year since last menstrual period.
- •13. Any other condition the Investigator believes would interfere with the patient’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
- •14. Plasma donation within one month of screening or any blood donation/blood loss >500 mL during the 3 months prior to Visit 2 or during the study.
- •15. Ongoing substitution therapy with pancreatic enzymes.
Investigators
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