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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Intervention: Creon (Drug); Creon 25000 matching Placebo (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Suntje Sander-Struckmeier, PhD, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)

Secondary outcome:

Change in nutritional parameters

Change in HbA1c

Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)

Change in clinical global impression of disease symptoms

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Site reference no. 113456, Bochum 44789, Germany

Site reference no. 113477, Frankfurt 60594, Germany

Site reference no. 113476, Pohlheim 35415, Germany

Site reference no. 113475, Ulm 89073, Germany

Site reference no. 112519, Madrid 28034, Spain

Site reference no. 112520, Málaga 29071, Spain

Site reference no. 112495, Santiago de Compostela 15706, Spain

Site reference no. 112518, Segovia 40002, Spain

Site reference no. 112496, Sevilla 41014, Spain

Site reference no. 112517, Ávila 05004, Spain

Additional Information

Starting date: November 2013
Last updated: June 19, 2014

Page last updated: August 23, 2015

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