Back to resultsA 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)
Primary Purpose
Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Epanova® (omega-3 carboxylic acids)
Omacor® (omega-3-acid ethyl esters)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring omega-3 carboxylic acid
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence AB
Sequence BA
Arm Description
A single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 7.
A single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 7.
Outcomes
Primary Outcome Measures
Part A: Serum TG Level.
For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).
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®.
Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.
Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.
Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.
Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02370537
Brief 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
Acronym
PRECISE
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
Keywords
omega-3 carboxylic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence AB
Arm Type
Experimental
Arm Description
A single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 7.
Arm Title
Sequence BA
Arm Type
Experimental
Arm Description
A single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 7.
Intervention Type
Drug
Intervention Name(s)
Epanova® (omega-3 carboxylic acids)
Other Intervention Name(s)
omega-3 carboxylic acids
Intervention Description
4 g (administered orally as 4 x 1 g capsules)
Intervention Type
Drug
Intervention Name(s)
Omacor® (omega-3-acid ethyl esters)
Other Intervention Name(s)
omega-3-acid ethyl esters
Intervention Description
4 g (administered orally as 4 x 1 g capsules)
Primary Outcome Measure Information:
Title
Part A: Serum TG Level.
Description
For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).
Time Frame
7 days after enrollment.
Title
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®.
Description
Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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.
Title
Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.
Description
Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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.
Title
Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
Description
Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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.
Title
Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.
Description
Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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.
Title
Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.
Description
Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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.
Title
Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.
Description
Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Research Site
City
Frederiksberg
Country
Denmark
Facility Name
Research Site
City
København NV
Country
Denmark
Facility Name
Research Site
City
Århus
Country
Denmark
Facility Name
Research Site
City
Balatonfüred
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Létavértes
Country
Hungary
Facility Name
Research Site
City
Daugavpils
Country
Latvia
Facility Name
Research Site
City
Jekabpils
Country
Latvia
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Białystok
Country
Poland
Facility Name
Research Site
City
Puławy
Country
Poland
Facility Name
Research Site
City
Staszów
Country
Poland
Facility Name
Research Site
City
Zamość
Country
Poland
Facility Name
Research Site
City
Bardejov
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Lubochna
Country
Slovakia
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Linköping
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29802077
Citation
Lindkvist B, Nilsson C, Kvarnstrom M, Oscarsson J. Importance of pancreatic exocrine dysfunction in patients with type 2 diabetes: A randomized crossover study. Pancreatology. 2018 Jul;18(5):550-558. doi: 10.1016/j.pan.2018.05.483. Epub 2018 May 19.
Results Reference
derived
Learn more about this trial
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
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