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

Abbott

Status and phase: Withdrawn; Phase 4

Conditions: Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Treatments: Drug: Creon; Drug: Creon 25000 matching Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02009410

M13-954

2013-001347-31 (EudraCT Number)

Details and patient eligibility

About

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

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Creon

Experimental group

Treatment:

Drug: Creon

Placebo

Placebo Comparator group

Treatment:

Drug: Creon 25000 matching Placebo