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

Primary Purpose

Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Creon
Creon 25000 matching Placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2 focused on measuring Exocrine Pancreatic Insufficiency

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Site reference no. 113456
  • Site reference no. 113477
  • Site reference no. 113476
  • Site reference no. 113475
  • Site reference no. 112519
  • Site reference no. 112520
  • Site reference no. 112495
  • Site reference no. 112518
  • Site reference no. 112496
  • Site reference no. 112517

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Creon

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in nutritional parameters
fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.
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
disease symptoms will be rated by the subject according a rating scale

Full Information

First Posted
November 25, 2013
Last Updated
June 19, 2014
Sponsor
Abbott
Collaborators
Nuvisan, Datamap, ClinIntel, Catalent
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1. Study Identification

Unique Protocol Identification Number
NCT02009410
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Nuvisan, Datamap, ClinIntel, Catalent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
Keywords
Exocrine Pancreatic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Creon
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Creon
Intervention Description
Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
Intervention Type
Drug
Intervention Name(s)
Creon 25000 matching Placebo
Intervention Description
Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
Primary Outcome Measure Information:
Title
Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)
Time Frame
from baseline up to the week 12 visit
Secondary Outcome Measure Information:
Title
Change in nutritional parameters
Description
fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.
Time Frame
from baseline up to the week 12 visit
Title
Change in HbA1c
Time Frame
from baseline up to the week 12 visit
Title
Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)
Time Frame
from baseline up to the week 12 visit
Title
Change in clinical global impression of disease symptoms
Description
disease symptoms will be rated by the subject according a rating scale
Time Frame
from baseline up to the week 12 visit
Other Pre-specified Outcome Measures:
Title
vital signs
Description
blood pressure and heart rate, body weight and BMI
Time Frame
from baseline up to the week 12 visit
Title
routine safety laboratory
Description
Hematology, biochemistry and a urine pregnancy test will be performed
Time Frame
from baseline up to the week 12 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suntje Sander-Struckmeier, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site reference no. 113456
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Site reference no. 113477
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Site reference no. 113476
City
Pohlheim
ZIP/Postal Code
35415
Country
Germany
Facility Name
Site reference no. 113475
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Site reference no. 112519
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Site reference no. 112520
City
Málaga
ZIP/Postal Code
29071
Country
Spain
Facility Name
Site reference no. 112495
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Site reference no. 112518
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
Site reference no. 112496
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Site reference no. 112517
City
Ávila
ZIP/Postal Code
05004
Country
Spain

12. IPD Sharing Statement

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

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