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

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:

Drug Information available for: Pancreatin Pancrelipase

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Change in nutritional parameters [ Time Frame: from baseline up to the week 12 visit ]
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 ]
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 ]
Change in clinical global impression of disease symptoms [ Time Frame: from baseline up to the week 12 visit ]
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 ]
blood pressure and heart rate, body weight and BMI
routine safety laboratory [ Time Frame: from baseline up to the week 12 visit ]
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 (Adult, Senior)
Sexes Eligible for Study:	All
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


Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT02009410 History of Changes
Other Study ID Numbers:	M13-954 2013-001347-31 ( EudraCT Number )
Study First Received:	November 25, 2013
Last Updated:	June 19, 2014

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 Pancrelipase Pancreatin Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 23, 2017