At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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')
In Brief
A Phase 1 clinical trial evaluating Placebo, Linagliptin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 42 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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)