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

• Status: Withdrawn
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborators: Catalent; ClinIntel; Datamap; Nuvisan
• Treatments: Pancreatin; Pancrelipase

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