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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Creon; Drug: Creon 25000 matching Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44789
    • Site reference no. 113456
  • Frankfurt, Germany, 60594
    • Site reference no. 113477
  • Pohlheim, Germany, 35415
    • Site reference no. 113476
  • Ulm, Germany, 89073
    • Site reference no. 113475
• Spain
  • Madrid, Spain, 28034
    • Site reference no. 112519
  • Málaga, Spain, 29071
    • Site reference no. 112520
  • Santiago de Compostela, Spain, 15706
    • Site reference no. 112495
  • Segovia, Spain, 40002
    • Site reference no. 112518
  • Sevilla, Spain, 41014
    • Site reference no. 112496
  • Ávila, Spain, 05004
    • Site reference no. 112517

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Creon 25000 matching Placebo; Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
Experimental: Creon	Drug: Creon; Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)	from baseline up to the week 12 visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nutritional parameters	fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.	from baseline up to the week 12 visit
Change in HbA1c		from baseline up to the week 12 visit
Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)		from baseline up to the week 12 visit
Change in clinical global impression of disease symptoms	disease symptoms will be rated by the subject according a rating scale	from baseline up to the week 12 visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital signs	blood pressure and heart rate, body weight and BMI	from baseline up to the week 12 visit
routine safety laboratory	Hematology, biochemistry and a urine pregnancy test will be performed	from baseline up to the week 12 visit

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Datamap; ClinIntel; Catalent; Nuvisan

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Exocrine Pancreatic Insufficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pancreatic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: M13-954; 2013-001347-31 (EudraCT Number)