| Trial ID: | L3211 |
| Source ID: | NCT01703286
|
| Associated Drug: |
Placebo
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| Title: |
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)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01703286/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: Linagliptin|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: Glimepiride
|
| Outcome Measures: |
Primary: 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., baseline and day 28 for each treatment arm | Secondary: 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., 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., baseline and day 28 for each treatment arm|Number of Patients With Adverse Events, Number of patients with any adverse events, up to 20 weeks
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-10
|
| Completion Date: |
2014-01
|
| Results First Posted: |
2015-01-19
|
| Last Update Posted: |
2015-01-19
|
| Locations: |
1218.105.001 Boehringer Ingelheim Investigational Site, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01703286
|
