A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2

Launched by ABBOTT · Dec 9, 2013

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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