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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Creon

Group Type EXPERIMENTAL

Creon

Intervention Type DRUG

Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Creon 25000 matching Placebo

Intervention Type DRUG

Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks

Interventions

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Creon

Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No