Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2Phase 4NCT02009410
A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
A Phase 4 study testing Creon in people with Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2, run by Abbott at 10 sites in 2 countries.
Trial summary
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
- What is being tested?
- Creon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Nov 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- BMI < 30 kg/m2
- History of type 2 diabetes mellitus as confirmed by:
- onset of diabetes after 30 years of age and
- no insulin treatment in the first year after diagnosis
- Subjects on insulin treatment or on insulin treatment in combination with oral antidiabetics
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- HbA1c > 6.5% in medical history within the last 6 months despite insulin treatment
- Not previously treated with any pancreatic enzyme supplementation
- FE-1 (fecal elastase 1) <100μg/g of stool
- 13C MTBT of <29% 13CO2-CRR (Carbon dioxide-Cumulative Recovery Rate)
Who cannot join
- Treatment with systemic steroids for at least 3 weeks within past 6 months
- Patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc.
- Any type of malignancy involving digestive tract in the last 5 years
- Any type of gastrointestinal surgery (except appendectomy and gallbladder resection)
- Short bowel syndrome
- Hemochromatosis
Show all 13Show fewer
- Known late onset autoimmune diabetes in the adult
- Any history of drug abuse including alcohol
- Positive urine pregnancy test; lactation; females of child-bearing potential who are not using either an oral hormonal contraceptive or an intrauterine device
- Hypersensitivity to the active substance or to any of the excipients
- Intake of an experimental drug within 4 weeks prior to entry into this study
- Suspected non-compliance or non-cooperation
- History of human immunodeficiency virus (HIV) infection
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain6 sites
Site reference no. 112517
Ávila, 05004
Site reference no. 112519
Madrid, 28034
Site reference no. 112520
Málaga, 29071
Site reference no. 112495
Santiago de Compostela, 15706
Site reference no. 112518
Segovia, 40002
Site reference no. 112496
Seville, 41014
Germany4 sites
Site reference no. 113456
Bochum, 44789
Site reference no. 113477
Frankfurt, 60594
Site reference no. 113476
Pohlheim, 35415
Site reference no. 113475
Ulm, 89073
About this study
Official title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
- Being tested
- Creon, Creon 25000 matching Placebo
- Keywords
- Exocrine Pancreatic Insufficiency
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreonDrug
Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
Creon 25000 matching PlaceboDrug
Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Creon | Experimental | Not described Receives: Drug: Creon |
| Placebo | Placebo comparator | Not described Receives: Drug: Creon 25000 matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)
Measured: from baseline up to the week 12 visit
Secondary outcomes (4)
Change in nutritional parameters
fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.
Measured: from baseline up to the week 12 visit
Change in HbA1c
Measured: from baseline up to the week 12 visit
Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)
Measured: from baseline up to the week 12 visit
Change in clinical global impression of disease symptoms
disease symptoms will be rated by the subject according a rating scale
Measured: from baseline up to the week 12 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nuvisan, Datamap, ClinIntel, Catalent
- Responsible party
- Sponsor
- Investigators
- Suntje Sander-Struckmeier, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009410
- Sponsor's protocol ID
- M13-954
- Other IDs
- 2013-001347-31
- Status last verified
- Jun 2014
- First submitted
- 25 Nov 2013
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT02009410
- Acronym / sponsor ID
- M13-954
- Keywords
- Exocrine Pancreatic Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Nuvisan, Datamap, ClinIntel, Catalent
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creon | Experimental | Drug: Creon |
| Placebo | Placebo comparator | Drug: Creon 25000 matching Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed Informed Consent
- BMI < 30 kg/m2
- History of type 2 diabetes mellitus as confirmed by:
- onset of diabetes after 30 years of age and
- no insulin treatment in the first year after diagnosis
Key exclusion criteria (13 listed)
- Treatment with systemic steroids for at least 3 weeks within past 6 months
- Patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc.
- Any type of malignancy involving digestive tract in the last 5 years
- Any type of gastrointestinal surgery (except appendectomy and gallbladder resection)
- Short bowel syndrome
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 |
|---|---|---|
| CreonCreon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks | Drug | Creon |
| Creon 25000 matching PlaceboCreon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks | Drug | Placebo |
Primary outcome
Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)
Time frame: from baseline up to the week 12 visit
4 secondary outcomes
Change in nutritional parameters
Time frame: from baseline up to the week 12 visit
Change in HbA1c
Time frame: from baseline up to the week 12 visit
Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)
Time frame: from baseline up to the week 12 visit
Change in clinical global impression of disease symptoms
Time frame: from baseline up to the week 12 visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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.
Suntje Sander-Struckmeier, PhD study director
Abbott
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Creon in people with Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2, run by Abbott at 10 sites in 2 countries.
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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Germany. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) (time frame: from baseline up to the week 12 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2014.