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

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

Official Title
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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

Conditions
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Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Creon
* Drug: Creon 25000 matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creon<br> | Drug: Creon<br>* Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Creon 25000 matching Placebo<br>* Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) |  | from baseline up to the week 12 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nutritional parameters | fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured. | from baseline up to the week 12 visit | 
| Change in HbA1c |  | from baseline up to the week 12 visit | 
| Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL) |  | 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 | from baseline up to the week 12 visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exocrine Pancreatic Insufficiency