| Trial ID: | L5781 |
| Source ID: | NCT02077309
|
| Associated Drug: |
Linagliptin
|
| Title: |
Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
Lina-Plaque
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2 (T2DM)|Vascular Inflammation|Plaque Morphology
|
| Interventions: |
DRUG: Linagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Effect of linagliptin on vascular inflammation of the carotic artery, Examination of the effect of 5 mg linagliptin qd versus placebo on vascular inflammation of the carotic artery by FDG-PET in patients with diabetes mellitus within 6 months., up to 6 months | Secondary: Effect of linagliptin on vessel wall volume of the carotid artery, Examination of the effect of 5mg linagliptin qd versus placebo on vessel wall volume of the carotid artery by MRI scan., baseline and 6 months|Effect of linagliptin on abdominal adipose tissue inflammation, Evaluation of the effect of 5mg linagliptin qd versus placebo on abdominal adipose tissue inflammation by FDG-PET in addition to adipose tissue biopsies., baseline and 6 months|Effect of linagliptin on biomarkers of vascular inflammation, Blood analysis to examine the effect of linagliptin on biomarkers of vascular inflammation., baseline and 6 months
|
| Sponsor/Collaborators: |
Sponsor: RWTH Aachen University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-08
|
| Completion Date: |
2015-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-04-12
|
| Locations: |
Department of Internal Medicine I, University Hospital, Aachen, 52074, Germany|Cardiovascular Research Institute Maastricht (CARIM), Maastricht, 6229, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT02077309
|
