1218.105.001 Boehringer Ingelheim Investigational Site
Neuss, Germany
NCT Number: NCT01703286
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Neuss, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Based upon a complete medical history and clinical laboratory tests
For female patients of childbearing potential:
Exclusion criteria
Placebo matching Glimepiride
given once daily for 28 days
1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)
Time frame: baseline and day 28 for each treatment arm
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
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
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: up to 20 weeks
Number of patients with any adverse events
Boehringer Ingelheim
Industry
Randomized, Three Period Cross Over, Double Blind, Double Dummy Study in Type 2 Diabetic Patients to Assess the Endothelial Effects of Linagliptin, Glimepiride and Placebo Therapy for 28 Days ('ENDOTHELINA')
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