Clinical Trial: A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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 Wit
Brief Summary: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
Detailed Summary:
Sponsor: Abbott
Current Primary Outcome: Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) [ Time Frame: from baseline up to the week 12 visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Abbott
Dates:
Date Received: November 25, 2013
Date Started: November 2013
Date Completion: August 2014
Last Updated: June 19, 2014
Last Verified: June 2014
