NCT02009410

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_4

Geographic Reach
2 countries

10 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

November 25, 2013

Last Update Submit

June 19, 2014

Conditions

Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Keywords

Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

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

    from baseline up to the week 12 visit

Secondary Outcomes (4)

  • Change in nutritional parameters

    from baseline up to the week 12 visit

  • 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

Other Outcomes (2)

  • vital signs

    from baseline up to the week 12 visit

  • routine safety laboratory

    from baseline up to the week 12 visit

Study Arms (2)

Creon

EXPERIMENTAL
Drug: Creon

Placebo

PLACEBO COMPARATOR
Drug: Creon 25000 matching Placebo

Interventions

CreonDRUG

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

Creon
Creon 25000 matching PlaceboDRUG

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

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • FE-1 (fecal elastase 1) \<100μg/g of stool
  • 13C MTBT of \<29% 13CO2-CRR (Carbon dioxide-Cumulative Recovery Rate)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Site reference no. 113456

Bochum, 44789, Germany

Location

Site reference no. 113477

Frankfurt, 60594, Germany

Location

Site reference no. 113476

Pohlheim, 35415, Germany

Location

Site reference no. 113475

Ulm, 89073, Germany

Location

Site reference no. 112517

Ávila, 05004, Spain

Location

Site reference no. 112519

Madrid, 28034, Spain

Location

Site reference no. 112520

Málaga, 29071, Spain

Location

Site reference no. 112495

Santiago de Compostela, 15706, Spain

Location

Site reference no. 112518

Segovia, 40002, Spain

Location

Site reference no. 112496

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

  • Suntje Sander-Struckmeier, PhD

    Abbott

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 12, 2013

Study Start

November 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

ES(6)DE(4)