| Trial ID: | L3874 |
| Source ID: | NCT02009410
|
| Associated Drug: |
Creon
|
| Title: |
A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Creon|DRUG: Creon 25000 matching Placebo
|
| Outcome Measures: |
Primary: Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon), from baseline up to the week 12 visit | Secondary: Change in nutritional parameters, fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured., 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, disease symptoms will be rated by the subject according a rating scale, from baseline up to the week 12 visit | Other: vital signs, blood pressure and heart rate, body weight and BMI, from baseline up to the week 12 visit|routine safety laboratory, Hematology, biochemistry and a urine pregnancy test will be performed, from baseline up to the week 12 visit
|
| Sponsor/Collaborators: |
Sponsor: Abbott | Collaborators: Nuvisan|Datamap|ClinIntel|Catalent
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-11
|
| Completion Date: |
2014-08
|
| Results First Posted: |
|
| Last Update Posted: |
2014-06-20
|
| Locations: |
Site reference no. 113456, Bochum, 44789, Germany|Site reference no. 113477, Frankfurt, 60594, Germany|Site reference no. 113476, Pohlheim, 35415, Germany|Site reference no. 113475, Ulm, 89073, Germany|Site reference no. 112519, Madrid, 28034, Spain|Site reference no. 112520, Málaga, 29071, Spain|Site reference no. 112495, Santiago de Compostela, 15706, Spain|Site reference no. 112518, Segovia, 40002, Spain|Site reference no. 112496, Sevilla, 41014, Spain|Site reference no. 112517, Ávila, 05004, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT02009410
|
