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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Nuvisan
Datamap
ClinIntel
Catalent
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT02009410
First received: November 25, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
Drug: Creon
Drug: Creon 25000 matching Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in nutritional parameters [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]
    fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.

  • Change in HbA1c [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in clinical global impression of disease symptoms [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]
    disease symptoms will be rated by the subject according a rating scale


Other Outcome Measures:
  • vital signs [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: Yes ]
    blood pressure and heart rate, body weight and BMI

  • routine safety laboratory [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: Yes ]
    Hematology, biochemistry and a urine pregnancy test will be performed


Enrollment: 0
Study Start Date: November 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009410

Locations
Germany
Site reference no. 113456
Bochum, Germany, 44789
Site reference no. 113477
Frankfurt, Germany, 60594
Site reference no. 113476
Pohlheim, Germany, 35415
Site reference no. 113475
Ulm, Germany, 89073
Spain
Site reference no. 112519
Madrid, Spain, 28034
Site reference no. 112520
Málaga, Spain, 29071
Site reference no. 112495
Santiago de Compostela, Spain, 15706
Site reference no. 112518
Segovia, Spain, 40002
Site reference no. 112496
Sevilla, Spain, 41014
Site reference no. 112517
Ávila, Spain, 05004
Sponsors and Collaborators
Abbott
Nuvisan
Datamap
ClinIntel
Catalent
Investigators
Study Director: Suntje Sander-Struckmeier, PhD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02009410     History of Changes
Other Study ID Numbers: M13-954, 2013-001347-31
Study First Received: November 25, 2013
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Exocrine Pancreatic Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014