A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
- Conditions
- Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
- Interventions
- Registration Number
- NCT02009410
- Lead Sponsor
- Abbott
- Brief Summary
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Creon 25000 matching Placebo - Creon Creon -
- Primary Outcome Measures
Name Time Method Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) from baseline up to the week 12 visit
- Secondary Outcome Measures
Name Time Method Change in nutritional parameters 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 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 from baseline up to the week 12 visit disease symptoms will be rated by the subject according a rating scale
Trial Locations
- Locations (10)
Site reference no. 112520
🇪🇸Málaga, Spain
Site reference no. 113475
🇩🇪Ulm, Germany
Site reference no. 113456
🇩🇪Bochum, Germany
Site reference no. 113477
🇩🇪Frankfurt, Germany
Site reference no. 113476
🇩🇪Pohlheim, Germany
Site reference no. 112518
🇪🇸Segovia, Spain
Site reference no. 112517
🇪🇸Ávila, Spain
Site reference no. 112519
🇪🇸Madrid, Spain
Site reference no. 112495
🇪🇸Santiago de Compostela, Spain
Site reference no. 112496
🇪🇸Sevilla, Spain