| Trial ID: | L6823 |
| Source ID: | NCT03639545
|
| Associated Drug: |
Empagliflozin 25mg
|
| Title: |
The Effects of Empagliflozin on Arterial Wall Characteristics
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Vascular Stiffness|Hypoglycemic Agents|Diabetes Complications|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Empagliflozin 25mg|DRUG: Metformin|DRUG: Empagliflozin/Metformin|DRUG: Placebos
|
| Outcome Measures: |
Primary: Arterial function, Endothelial function and arterial stiffness will be measured., the change of arterial function from baseline to 12 weeks of treatment | Secondary: Glycemic control, HbA1c will be measured., the change of HbA1c from baseline to 12 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: University Medical Centre Ljubljana
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-03-01
|
| Completion Date: |
2019-01-30
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-21
|
| Locations: |
University Medical Centre Ljubljana, Ljubljana, SI-1000, Slovenia
|
| URL: |
https://clinicaltrials.gov/show/NCT03639545
|
