Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01703286|
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Placebo Drug: Linagliptin Drug: Glimepiride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||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')|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Linagliptin 5mg
given once daily over 28 days
Placebo matching GlimepirideDrug: Linagliptin
given once daily for 28 days
Active Comparator: Glimepiride
given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days
Placebo matching LinagliptinDrug: Glimepiride
1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)
Placebo Comparator: Placebo
given once daily over 28 days
Placebo matching LinagliptinDrug: Placebo
Placebo matching Glimepiride
- Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28 [ 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.
- Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28 [ 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.
- Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28 [ 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.
- Number of Patients With Adverse Events [ Time Frame: up to 20 weeks ]Number of patients with any adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703286
|1218.105.001 Boehringer Ingelheim Investigational Site|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|