Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
Conditions
Keywords
Exocrine Pancreatic Insufficiency
Brief summary
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
Interventions
DRUGCreon
Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
DRUGCreon 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
Sponsors
Nuvisan
Datamap
ClinIntel
Catalent
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) | from baseline up to the week 12 visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| vital signs | from baseline up to the week 12 visit | blood pressure and heart rate, body weight and BMI |
| routine safety laboratory | from baseline up to the week 12 visit | Hematology, biochemistry and a urine pregnancy test will be performed |
Countries
Germany, Spain
Outcome results
None listed