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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370537
• Other study ID #: D5881C00006
• Secondary ID: 2014-003511-11
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2015
• Last updated: November 30, 2015
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exocrine Pancreatic Insufficiency

Intervention

Drug:
• Epanova® (omega-3 carboxylic acids)
4 g (administered orally as 4 x 1 g capsules)
• Omacor® (omega-3-acid ethyl esters)
4 g (administered orally as 4 x 1 g capsules)

Locations

Country	Name	City	State
Denmark	Research Site	Århus
Denmark	Research Site	Frederiksberg
Denmark	Research Site	København NV
Hungary	Research Site	Balatonfüred
Hungary	Research Site	Budapest
Hungary	Research Site	Létavértes
Latvia	Research Site	Daugavpils
Latvia	Research Site	Jekabpils
Latvia	Research Site	Riga
Poland	Research Site	Bialystok
Poland	Research Site	Pulawy
Poland	Research Site	Staszów
Poland	Research Site	Zamosc
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Lubochna
Sweden	Research Site	Göteborg
Sweden	Research Site	Linköping
Sweden	Research Site	Lund
Sweden	Research Site	Malmo
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Hungary,  Latvia,  Poland,  Slovakia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Serum triglyceride (TG) level	For Part A, the distribution of serum TG levels by the degree of PEI will be summarized.	7 days	No
Primary	Part B: PK of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) by assessment of AUC0-t	Baseline-corrected area under plasma concentration time curve from time 0 to the last measurable concentration (AUC0-t) will be measured for the sum of DHA+EPA, and EPA and DHA separately.	48 hours	No
Primary	Part B: PK of DHA and EPA by assessment of AUC	Area under plasma concentration-time curve from zero to infinity (AUC) will be measured for the sum of DHA+EPA, and EPA and DHA separately.	48 hours	No
Primary	Part B: PK of DHA and EPA by assessment of Cmax	Maximum plasma drug concentration (Cmax) will be measured for the sum of DHA+EPA, and EPA and DHA separately.	48 hours	No