Clinical Drug Experience Knowledgebase

Criteria

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