The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors. Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Placebo matching Glimepiride
given once daily for 28 days
Placebo matching Linagliptin
Placebo matching Linagliptin
Placebo matching Glimepiride
1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)
1218.105.001 Boehringer Ingelheim Investigational Site
Neuss, Germany
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28
Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Time frame: baseline and day 28 for each treatment arm
Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28
Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Time frame: baseline and day 28 for each treatment arm
Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28
Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Time frame: baseline and day 28 for each treatment arm
Number of Patients With Adverse Events
Number of patients with any adverse events
Time frame: up to 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.