Patients with pancreatic exocrine insufficiency (PEI) secondary to type 1 diabetes mellitus (DM)
Conditions
Interventions
Trade Name: Kreon 25.000
Product Name: Creon 25.000
Product Code: PL 00512/0150
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral us
Sponsors
Fundación para la Investigación en Enfermedades del Aparato Digestivo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients older than 18 with type 1 DM as defined according to the ADA guidelines (see below). • Written informed consent. • After visit 1: Presence of two or more abnormal hematological and/or biochemical nutritional parameters. • After visit 2: PEI diagnosed by the 13C-MTG breath test and defined as a 13C-CCR =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age < 18 years. • Pregnancy or lactancy. • Unwillingness or inability to understand the study and sign the consent, or to accomplish with the visits and procedures of the study. • Diagnosis of chronic pancreatitis, pancreatic cancer or any other disease or condition potentially associated with PEI. • Previous gastrointestinal surgery other than appendectomy and cholecystectomy. • Any kind of uncured malignant disease. • Known allergy to products of porcine origin. • Need of any therapy known to influence pancreatic secretion (e.g. somatostatin and somatostatin analogues). • Severe gastroparesia leading to frequent vomiting and malnourishment. • Intake of any experimental drug within 4 weeks before entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior efficacy of pancreatic enzymes over placebo in improving digestion in subjects suffering from PEI secondary to type 1 DM. The primary efficacy parameter will be the change in the 13C-cumulative recovery rate (CRR) from baseline to treatment as evaluated by the 13C-MTG breath test;Secondary Objective: 1. To investigate the prevalence of PEI in patients with type 1 DM and the potential factors associated with PEI, among them age, gender, years of disease, alcohol intake, smoking, BMI, presence of glutamic acid decarboxylase antibody (GAD) or insulinoma-associated protein 2 (IA2), diabetic control as evaluated by the circulating levels of HbA1C, frequency of ketoacidosis and hypoglycemic events, daily insulin dose requirements, and presence of neuropathy and vascular disease (retinopathy, nephropathy). 2. To evaluate the effect of PERT compared to placebo on glycemic control (HbA1C), abdominal symptoms (abdominal pain, distention and discomfort, postprandial fullness, early satiety, meteorism, bloating, stool frequency and consistency, flatulence), quality of life (QoL SF-36) and nutritional status (hematologic and biochemical nutritional parameters). 3. To evaluate the safety and tolerability of PERT in type 1 DM, including vital signs, safety laboratory values and adverse events.;Primary end point(s): Difference in fat digestion as measured by the 13C-MTG breath test (13C-CCR) from basal to therapy (PERT or placebo).;Timepoint(s) of evaluation of this end point: Four weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Prevalence of PEI in patients with DM type 1, difference in glycemic control, symptoms, QoL and nutritional status between PERT and placebo at month 1 (symptoms), 3 and 6 after randomization.;Timepoint(s) of evaluation of this end point: Three and six months | — |
Countries
Spain
Contacts
Public ContactJ. Enrique Dominguez-Munoz
Fundación para la Investigación en Enfermedades del Aparato Digestivo
Outcome results
None listed