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: EUCTR
• Last refreshed on: 22 December 2015
• Main ID: EUCTR2014-003511-11-HU
• Date of registration: 29/12/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• 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
• 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 - PRECISE
• Date of first enrolment: 13/02/2015
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003511-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark, Hungary, Latvia, Poland, Slovakia, Sweden

Contacts

• Name: Information Center
• Affiliation: AstraZeneca

• Name: Information Center
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes
MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: Epanova
Product Code: Epanova
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: NA
Current Sponsor code: Omefas
Other descriptive name: OMEGA-3 FATTY ACIDS
Concentration unit: mg/g milligram(s)/gram
Concentration type: not less then
Concentration number: 800-

Trade Name: Omacor
Product Name: Omacor
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Omacor
Current Sponsor code: Omacor
Other descriptive name: Omega-3-acid ethyl esters
Concentration unit: mg/g milligram(s)/gram
Concentration type: not less then
Concentration number: 900-

Primary Outcome(s)

Main Objective: The primary objective of Part A of the trial is to describe the distribution of plasma triglycerides in patients with Type 2 Diabetes Mellitus by degree of pancreatic exocrine insufficiency (Normal: faecal elastase-1 concentration [FEC] =200 µg/g; Intermediate: FEC =100 µg/g to <200 µg/g; and Low: FEC <100 µg/g). The primary objective of Part B of the trial is to evaluate and compare the plasma exposure of docosahexaenoic acid and eicosapentaenoic acid from EPANOVA® and OMACOR®, respectively, in patients with Type 2 Diabetes Mellitus with different levels of FEC.

Primary end point(s): The primary outcome measures for Part A are plasma triglyceride levels and faecal elastase-1 concentration at the end of Part A. The primary outcome measures for Part B are baseline-corrected area under plasma concentration time curve from time 0 to the last measurable
concentration (AUC0-t), area under plasma concentration-time curve from zero to infinity (AUC)
and maximum plasma drug concentration (Cmax) of the sum of DHA+EPA, and EPA and DHA
separately, during Part B.

Timepoint(s) of evaluation of this end point: Part A: Day 7±2 days; Part B: Visit 4 (Day 21) and Visit 7 (10-14 days after Visit 4): 1, 2, 3, 4, 5, 6, 7, 8 and 10 hours after dosing; Visit 5 (1 day after Visit 4), Visit 6 (2 days after Visit 4), Visit 8 (1 day after Visit 7), and Visit 9 (2 days after Visit 7): 24 and 48 hours after dosing.

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

D5881C00006

2014-003511-11-SK

Source(s) of Monetary Support

AstraZeneca AB