Diabetes Mellitus, Type 2Phase 2PRECISENCT02370537

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

A Phase 2 study testing Epanova® (omega-3 carboxylic acids) and Omacor® (omega-3-acid ethyl esters) in people with Diabetes Mellitus, Type 2 and Exocrine Pancreatic Insufficiency, run by AstraZeneca at 22 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
What is being tested?: Epanova® (omega-3 carboxylic acids) and Omacor® (omega-3-acid ethyl esters)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 490 participants
Where: 22 sitesin 6 countries
Study dates: Mar 2015to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

22 sites in 6 countries.

Country

City, postcode or hospital

22 sites in 6 countries

Sweden6 sites

Research Site
Gothenburg
Research Site
Linköping
Research Site
Lund
Research Site
Malmö
Research Site
Stockholm
Research Site
Uppsala

Other trials in Sweden

Poland4 sites

Research Site
Bialystok
Research Site
Puławy
Research Site
Staszów
Research Site
Zamość

Other trials in Poland

Denmark3 sites

Research Site
Aarhus
Research Site
Frederiksberg
Research Site
København NV

Other trials in Denmark

Hungary3 sites

Research Site
Balatonfüred
Research Site
Budapest
Research Site
Létavértes

Other trials in Hungary

Latvia3 sites

Research Site
Daugavpils
Research Site
Jēkabpils
Research Site
Riga

Other trials in Latvia

Slovakia3 sites

Research Site
Bardejov
Research Site
Bratislava
Research Site
Ľubochňa

Other trials in Slovakia

About this study

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

Conditions: Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
Being tested: Epanova® (omega-3 carboxylic acids), Omacor® (omega-3-acid ethyl esters)
Keywords: omega-3 carboxylic acid
Medical subject headings: Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02370537
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Epanova® (omega-3 carboxylic acids); Drug: Omacor® (omega-3-acid ethyl esters)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Nov 2015

First posted25 Feb 2015 (estimated)
Study startMar 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02370537
Sponsor's protocol ID: D5881C00006
Other IDs: 2014-003511-11, 2014
Acronym: PRECISE
Status last verified: Nov 2016
First submitted: 24 Feb 2015
Last updated: 20 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29802077

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02370537
Acronym / sponsor ID: PRECISE / D5881C00006
Conditions: Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
Keywords: omega-3 carboxylic acid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 490 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 25 Feb 2015 (estimated)
Results: Posted 20 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence AB	Experimental	Drug: Epanova® (omega-3 carboxylic acids), Drug: Omacor® (omega-3-acid ethyl esters)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.
Sequence BA	Experimental	Drug: Epanova® (omega-3 carboxylic acids), Drug: Omacor® (omega-3-acid ethyl esters)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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epanova® (omega-3 carboxylic acids)Also: omega-3 carboxylic acids4 g (administered orally as 4 x 1 g capsules)	Drug	Sequence AB, Sequence BA
Omacor® (omega-3-acid ethyl esters)Also: omega-3-acid ethyl esters4 g (administered orally as 4 x 1 g capsules)	Drug	Sequence AB, Sequence BA

Primary outcome

Part A: Serum TG Level.
Time frame: 7 days after enrollment.
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®.
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.
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®.
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.
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®.
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.
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®.
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.
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®.
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.
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®.
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.
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.

Results and safety

Results posted to the registry on 20 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low FEC (EPANOVA® and OMACOR®)	16	16
Intermediate FEC (EPANOVA® and OMACOR®)	16	15
Normal FEC (EPANOVA® and OMACOR®)	283	282

Primary outcome: Part A: Serum TG Level.

Time frame: 7 days after enrollment.. Mean (Standard Deviation). Unit: millimole per litre (mmol/L)

Measure	Low FEC (EPANOVA® and OMACOR®) n = 15	Intermediate FEC (EPANOVA® and OMACOR®) n = 16	Normal FEC (EPANOVA® and OMACOR®) n = 278
Value	2.07 (0.63)	1.68 (0.57)	2.00 (1.16)

Population analysed: The Per Protocol Analysis Set included all enrolled patients without an important protocol deviation.

Primary outcome: 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®.

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.. Geometric mean (Geometric Coefficient of Variation). Unit: hours*mcg per millilitre (h*mcg/mL)

Measure	Low FEC (EPANOVA®) n = 15	Low FEC (OMACOR®) n = 14	Intermediate FEC (EPANOVA®) n = 13	Intermediate FEC (OMACOR®) n = 12	Normal FEC (EPANOVA®) n = 21	Normal FEC (OMACOR®) n = 22
Value	2170 (65.2)	1650 (31.3)	2000 (82.8)	946 (96.0)	2070 (36.1)	1260 (126)

Low FEC (EPANOVA®) vs Low FEC (OMACOR®): Geometric least-squares (GLS) Mean Ratio: 0.75 (90% CI 0.52 to 1.10)
Intermediate FEC (EPANOVA®) vs Intermediate FEC (OMACOR®): GLS Mean ratio: 0.48 (90% CI 0.32 to 0.72)
Normal FEC (EPANOVA®) vs Normal FEC (OMACOR®): GLS Mean Ratio: 0.6 (90% CI 0.44 to 0.82)

Population analysed: The Pharmacokinetic (PK) Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.

Primary outcome: Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.

Measure	Low FEC (EPANOVA®) n = 15	Low FEC (OMACOR®) n = 14	Intermediate FEC (EPANOVA®) n = 13	Intermediate FEC (OMACOR®) n = 12	Normal FEC (EPANOVA®) n = 21	Normal FEC (OMACOR®) n = 22
Value	801 (55.7)	1040 (47.1)	719 (85.0)	567 (70.7)	625 (90.2)	810 (105)

Low FEC (EPANOVA®) vs Low FEC (OMACOR®): GLS Mean Ratio: 1.28 (90% CI 0.84 to 1.93)
Intermediate FEC (EPANOVA®) vs Intermediate FEC (OMACOR®): GLS Mean Ratio: 0.80 (90% CI 0.51 to 1.25)
Normal FEC (EPANOVA®) vs Normal FEC (OMACOR®): GLS Mean Ratio: 1.29 (90% CI 0.92 to 1.82)

Population analysed: The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.

Primary outcome: Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.

Measure	Low FEC (EPANOVA®) n = 15	Low FEC (OMACOR®) n = 14	Intermediate FEC (EPANOVA®) n = 13	Intermediate FEC (OMACOR®) n = 12	Normal FEC (EPANOVA®) n = 21	Normal FEC (OMACOR®) n = 22
Value	9700 (57.7)	8780 (32.9)	8990 (72.4)	5130 (80.6)	8890 (43.8)	6690 (112)

Low FEC (EPANOVA®) vs Low FEC (OMACOR®): GLS Mean Ratio: 0.90 (90% CI 0.63 to 1.28)
Intermediate FEC (EPANOVA®) vs Intermediate FEC (OMACOR®): GLS Mean Ratio: 0.58 (90% CI 0.39 to 0.85)
Normal FEC (EPANOVA®) vs Normal FEC (OMACOR®): GLS Mean Ratio: 0.75 (90% CI 0.55 to 1.00)

Adverse events

Time frame: All adverse events (AEs) were collected until the safety follow-up contact (Visit 10). Serious AEs were collected from Visit 1 (screening) onwards over a period of up to 13 weeks. Other AEs were recorded from Visit 2 over a period of 7 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low FEC (EPANOVA®)	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Low FEC (OMACOR®)	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Intermediate FEC (EPANOVA®)	0 of 13 (0%)	0 of 13 (0%)	Not reported
Intermediate FEC (OMACOR®)	1 of 12 (8.3%)	0 of 12 (0%)	Not reported
Normal FEC (EPANOVA®)	0 of 23 (0%)	5 of 23 (21.7%)	Not reported
Normal FEC (OMACOR®)	0 of 23 (0%)	1 of 23 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29802077Lindkvist 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

22 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Sweden, Poland, Denmark, Hungary, Latvia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Serum TG Level. (time frame: 7 days after enrollment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02370537, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.