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

NCT02009410 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-06-20

No results posted yet for this study

Summary

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

Conditions

  • Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Interventions

DRUG

Creon

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

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

Sponsors & Collaborators

  • Nuvisan

    collaborator UNKNOWN

  • Datamap

    collaborator INDUSTRY

  • ClinIntel

    collaborator INDUSTRY

  • Catalent

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Suntje Sander-Struckmeier, PhD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009410 on ClinicalTrials.gov