Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2 Clinical Trial
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
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Site reference no. 113456 | Bochum | |
| Germany | Site reference no. 113477 | Frankfurt | |
| Germany | Site reference no. 113476 | Pohlheim | |
| Germany | Site reference no. 113475 | Ulm | |
| Spain | Site reference no. 112517 | Ávila | |
| Spain | Site reference no. 112519 | Madrid | |
| Spain | Site reference no. 112520 | Málaga | |
| Spain | Site reference no. 112495 | Santiago de Compostela | |
| Spain | Site reference no. 112518 | Segovia | |
| Spain | Site reference no. 112496 | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott | Catalent, ClinIntel, Datamap, Nuvisan |
Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | vital signs | blood pressure and heart rate, body weight and BMI | from baseline up to the week 12 visit | Yes |
| Other | routine safety laboratory | Hematology, biochemistry and a urine pregnancy test will be performed | from baseline up to the week 12 visit | Yes |
| Primary | Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) | from baseline up to the week 12 visit | No | |
| Secondary | 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 | No |
| Secondary | Change in HbA1c | from baseline up to the week 12 visit | No | |
| Secondary | Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL) | from baseline up to the week 12 visit | No | |
| Secondary | 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 | No |