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

Conditions: Pancreatic exocrine insufficiency in diabetes type II
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-001347-31-ES

Lead Sponsor: Abbott Laboratories GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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
?FE-1 <100?g/g of stool
?13C MTBT of <29% 13CO2-CRR
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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