Clinical trial NCT02009410: A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
Official title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
Keywords: Exocrine Pancreatic Insufficiency
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Nuvisan
name: Datamap
name: ClinIntel
name: Catalent
First posted: 2013-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)
timeFrame: from baseline up to the week 12 visit
Secondary outcomes:
measure: Change in nutritional parameters
timeFrame: from baseline up to the week 12 visit
measure: Change in HbA1c
timeFrame: from baseline up to the week 12 visit
measure: Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)
timeFrame: from baseline up to the week 12 visit
measure: Change in clinical global impression of disease symptoms
timeFrame: from baseline up to the week 12 visit
Other outcomes:
measure: vital signs
timeFrame: from baseline up to the week 12 visit
measure: routine safety laboratory
timeFrame: from baseline up to the week 12 visit
Locations:
city: Bochum
country: Germany
facility: Site reference no. 113456
city: Frankfurt
country: Germany
facility: Site reference no. 113477
city: Pohlheim
country: Germany
facility: Site reference no. 113476
city: Ulm
country: Germany
facility: Site reference no. 113475
city: Madrid
country: Spain
facility: Site reference no. 112519
city: Málaga
country: Spain
facility: Site reference no. 112520
city: Santiago de Compostela
country: Spain
facility: Site reference no. 112495
city: Segovia
country: Spain
facility: Site reference no. 112518
city: Sevilla
country: Spain
facility: Site reference no. 112496
city: Ávila
country: Spain
facility: Site reference no. 112517
Study officials:
affiliation: Abbott
name: Suntje Sander-Struckmeier, PhD
role: STUDY_DIRECTOR
References: