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

Sponsor

Abbott (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02009410

Collaborator

Nuvisan (Other), Datamap (Industry), ClinIntel (Industry), Catalent (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2014

Anticipated Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) [from baseline up to the week 12 visit]

Secondary Outcome Measures

Change in nutritional parameters [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 [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 [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 [from baseline up to the week 12 visit]
blood pressure and heart rate, body weight and BMI
routine safety laboratory [from baseline up to the week 12 visit]
Hematology, biochemistry and a urine pregnancy test will be performed

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site reference no. 113456	Bochum	Germany	44789
2	Site reference no. 113477	Frankfurt	Germany	60594
3	Site reference no. 113476	Pohlheim	Germany	35415
4	Site reference no. 113475	Ulm	Germany	89073
5	Site reference no. 112519	Madrid	Spain	28034
6	Site reference no. 112520	Málaga	Spain	29071
7	Site reference no. 112495	Santiago de Compostela	Spain	15706
8	Site reference no. 112518	Segovia	Spain	40002
9	Site reference no. 112496	Sevilla	Spain	41014
10	Site reference no. 112517	Ávila	Spain	05004