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
Conditions
Interventions
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
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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
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 500 mL during the 3 months prior to Visit 2 or during the study. 15. Ongoing substitution therapy with pancreatic enzymes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: Not applicable;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Hungary, Latvia, Poland, Slovakia, Sweden
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed