Pancreatic exocrine insufficiency in diabetes type II
Conditions
Interventions
Trade Name: Kreon 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not assigned
CAS Number: 8049-47-6
Other descriptive name: PANCREATIN
Concentration unit: IU international unit(s)
Conce
Sponsors
Abbott Laboratories GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Signed Informed Consent ? BMI 6.5% in medical history within the last 6 months despite insulin treatment ? Not previously treated with any pancreatic enzyme supplementation ? FE-1 =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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. ? Known allergy to products of porcine origin ? 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 ? 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 ? Severe allergy or any history of severe abnormal drug reaction ? 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 |
|---|---|
| Main Objective: To evaluate the effect of Creon 25000 versus placebo on fat digestion as measured by the 13C Mixed Triglycerides Breath Test (MTBT) in patients with pancreatic exocrine insufficiency (PEI) and type 2 diabetes mellitus (DM).;Secondary Objective: Secondary Objectives: To assess the effect of Creon on nutritional parameters (fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magnesium, calcium), HbA1c, quality of life assessed via a questionnaire (Gastrointestinal-Quality of Life Index, GIQLI), Clinical Global Impression of Disease Symptoms, clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence), and use of anti-diabetic medication. Safety and Tolerability Objectives: To evaluate the safety and tolerability of Creon in type 2 DM patients with PEI by collecting treatment-emergent adverse events (TEAE), vital signs (incl. body weight and BMI), physical examination and routine safety laboratory.;Primary end point(s): The primary efficacy parameter will be the change from baseline to the end of the double-blind treatment in the 6-hour 13CO2?CRR as measured by the 13C MTBT.;Timepoint(s) of evaluation of this end point: Change from baseline after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? nutritional parameters (fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magnesium and calcium), ? HbA1c, ? quality of life (QoL) assessed via a questionnaire (GIQLI), ? Clinical Global Impression (CGI) of Disease Symptoms, ? clinical symptomatology (stool frequency, stool consistency, abdominal pain, and flatulence), ? Use of anti-diabetic medication (insulin and, if applicable, oral anti-diabetic medication). The safety and tolerability data collected during this study are vital signs, height, weight and BMI, safety laboratory values and adverse events.;Timepoint(s) of evaluation of this end point: Secondary efficacy parameters are evaluated by the change from baseline to 12 week of treatment. Safety parameters are assessed throughout the study. | — |
Countries
Spain
Contacts
Public ContactGlobal Clinical Trial Management
Abbott Healthcare Products BV
Outcome results
None listed