NCT02370537

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
6 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

February 24, 2015

Results QC Date

September 13, 2016

Last Update Submit

November 25, 2016

Conditions

Diabetes Mellitus, Type 2Exocrine Pancreatic Insufficiency

Keywords

omega-3 carboxylic acid

Outcome Measures

Primary Outcomes (7)

  • 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).

    7 days after enrollment.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

Study Arms (2)

Sequence AB

EXPERIMENTAL

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.

Drug: Epanova® (omega-3 carboxylic acids)Drug: Omacor® (omega-3-acid ethyl esters)

Sequence BA

EXPERIMENTAL

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.

Drug: Epanova® (omega-3 carboxylic acids)Drug: Omacor® (omega-3-acid ethyl esters)

Interventions

Epanova® (omega-3 carboxylic acids)DRUG

4 g (administered orally as 4 x 1 g capsules)

Also known as: omega-3 carboxylic acids
Sequence ABSequence BA
Omacor® (omega-3-acid ethyl esters)DRUG

4 g (administered orally as 4 x 1 g capsules)

Also known as: omega-3-acid ethyl esters
Sequence ABSequence BA

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Research Site

Aarhus, Denmark

Location

Research Site

Frederiksberg, Denmark

Location

Research Site

København NV, Denmark

Location

Research Site

Balatonfüred, Hungary

Location

Research Site

Budapest, Hungary

Location

Research Site

Létavértes, Hungary

Location

Research Site

Daugavpils, Latvia

Location

Research Site

Jēkabpils, Latvia

Location

Research Site

Riga, Latvia

Location

Research Site

Bialystok, Poland

Location

Research Site

Puławy, Poland

Location

Research Site

Staszów, Poland

Location

Research Site

Zamość, Poland

Location

Research Site

Bardejov, Slovakia

Location

Research Site

Bratislava, Slovakia

Location

Research Site

Ľubochňa, Slovakia

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Lund, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 29802077DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Exocrine Pancreatic Insufficiency

Interventions

Omacor

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPancreatic DiseasesDigestive System Diseases

Results Point of Contact

Title
Stefan Carlsson
Organization
AstraZeneca AB
Stefan.C.Carlsson@astrazeneca.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

February 25, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 20, 2017

Results First Posted

January 20, 2017

Record last verified: 2016-11

Locations

DK(3)HU(3)LA(3)SE(6)PL(4)SL(3)