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