A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) [ Time Frame: from baseline up to the week 12 visit ]

Secondary Outcome Measures :

1. 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.
2. Change in HbA1c [ Time Frame: from baseline up to the week 12 visit ]
3. 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 ]
4. 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

Other Outcome Measures:

1. vital signs [ Time Frame: from baseline up to the week 12 visit ]
   blood pressure and heart rate, body weight and BMI
2. routine safety laboratory [ Time Frame: from baseline up to the week 12 visit ]
   Hematology, biochemistry and a urine pregnancy test will be performed

Eligibility Criteria

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Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Abbott

Nuvisan

Datamap

ClinIntel

Catalent

Investigators

Study Director:	Suntje Sander-Struckmeier, PhD	Abbott

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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