A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
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ClinicalTrials.gov Identifier: NCT02009410 |
Recruitment Status
:
Withdrawn
First Posted
: December 12, 2013
Last Update Posted
: June 20, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2 | Drug: Creon Drug: Creon 25000 matching Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2013 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Creon |
Drug: Creon
Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
|
Placebo Comparator: Placebo |
Drug: Creon 25000 matching Placebo
Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
|
- Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) [ Time Frame: from baseline up to the week 12 visit ]
- Change in nutritional parameters [ Time Frame: from baseline up to the week 12 visit ]fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.
- 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 ]disease symptoms will be rated by the subject according a rating scale
- vital signs [ Time Frame: from baseline up to the week 12 visit ]blood pressure and heart rate, body weight and BMI
- routine safety laboratory [ Time Frame: from baseline up to the week 12 visit ]Hematology, biochemistry and a urine pregnancy test will be performed

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Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- HbA1c > 6.5% in medical history within the last 6 months despite insulin treatment
- Not previously treated with any pancreatic enzyme supplementation
Inclusion Criterion at Visit 1:
• FE-1 (fecal elastase 1) <100μg/g of stool
Inclusion Criterion at Visit 2:
• 13C MTBT of <29% 13CO2-CRR (Carbon dioxide-Cumulative Recovery Rate)
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009410
Germany | |
Site reference no. 113456 | |
Bochum, Germany, 44789 | |
Site reference no. 113477 | |
Frankfurt, Germany, 60594 | |
Site reference no. 113476 | |
Pohlheim, Germany, 35415 | |
Site reference no. 113475 | |
Ulm, Germany, 89073 | |
Spain | |
Site reference no. 112519 | |
Madrid, Spain, 28034 | |
Site reference no. 112520 | |
Málaga, Spain, 29071 | |
Site reference no. 112495 | |
Santiago de Compostela, Spain, 15706 | |
Site reference no. 112518 | |
Segovia, Spain, 40002 | |
Site reference no. 112496 | |
Sevilla, Spain, 41014 | |
Site reference no. 112517 | |
Ávila, Spain, 05004 |
Study Director: | Suntje Sander-Struckmeier, PhD | Abbott |
Responsible Party: | Abbott |
ClinicalTrials.gov Identifier: | NCT02009410 History of Changes |
Other Study ID Numbers: |
M13-954 2013-001347-31 ( EudraCT Number ) |
First Posted: | December 12, 2013 Key Record Dates |
Last Update Posted: | June 20, 2014 |
Last Verified: | June 2014 |
Keywords provided by Abbott:
Exocrine Pancreatic Insufficiency |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Exocrine Pancreatic Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pancreatic Diseases Digestive System Diseases Pancrelipase Pancreatin Gastrointestinal Agents |