Clinical Trials Directory

Trials / Terminated

TerminatedNCT02077309

Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Linagliptin as a Modulator of Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
4 (actual)
Sponsor
RWTH Aachen University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

Examination of the effect of Linagliptin versus placebo for 6 months on vascular inflammation of the carotic artery and on abdominal adipose tissue inflammation in patients with diabetes mellitus type 2. The effect will be assessed by FDG-PET scan. Furthermore the effect of Linagliptin on the vessel wall volume of the carotid artery will be assessed by MRI scan and biomarkers of vascular inflammation will be analyzed in blood samples.

Detailed description

As part of the screening a PET-CT scan is executed to examine baseline vascular inflammation of the carotid artery and to evaluate abdominal adipose tissues inflammation. Patients who are eligible to participate in the study according to the in- and exclusion criteria will be randomised in one of the two study arms. According to the randomisation the patients will receive 5 mg Linagliptin or placebo per day for a period of 6 months. To evaluate the effect of Linagliptin versus placebo the vessel wall volume of the artery will be assessed by MRI scan and the vascular inflammation of the carotid artery by FDG-PET, furthermore the vascular inflammation will be analyzed by biomarkers in blood samples and the abdominal adipose tissue inflammation will investigated by subcutaneous adipose tissue biopsies.

Conditions

Interventions

TypeNameDescription
DRUGLinagliptin
DRUGPlacebo

Timeline

Start date
2014-08-01
Primary completion
2015-09-01
Completion
2015-11-01
First posted
2014-03-04
Last updated
2017-04-12

Locations

2 sites across 2 countries: Germany, Netherlands

Source: ClinicalTrials.gov record NCT02077309. Inclusion in this directory is not an endorsement.