| Trial ID: | L2215 |
| Source ID: | NCT03437330
|
| Associated Drug: |
Empagliflozin (Jardiance®)
|
| Title: |
Empagliflozin Effect on Glucose Toxicity
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes Mellitus
|
| Interventions: |
DRUG: Empagliflozin (Jardiance®)|DRUG: Insulin Glargine (Lantus®)
|
| Outcome Measures: |
Primary: Change in skeletal muscle H202 concentration between baseline and end of treatment (EoT), The primary objective is to investigate the change in H2O2 concentration as a read out of reactive oxygen species (ROS) production in skeletal muscle biopsies from T2DM patients before and after treatment with empagliflozin or insulin glargine., 12 weeks | Secondary: Secondary objectives of the study are to evaluate the effect of empagliflozin and insulin glargine on glucose toxicity in skeletal muscle by investigating, Change in skeletal muscle mitochondrial function (O2consumption) between baseline and EoT, 12 weeks|Change in skeletal muscle lipid peroxidation, Change in skeletal muscle lipid peroxidation between baseline and EoT, 12 weeks|Change in 24-hour urinary excretion rate of 8-iso PGF2a, Change in 24-hour urinary excretion rate of 8-iso PGF2a between baseline and EoT, 12 weeks|• Difference in DNA methylation pattern, • Difference in DNA methylation pattern between the treatment groups at EoT, 12 weeks|Change in plasma FFA levels, Change in plasma FFA levels between baseline and end of trial, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Tuebingen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-10-27
|
| Completion Date: |
2023-05-03
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-16
|
| Locations: |
University Hospital, Tuebingen, Baden-Württemberg, 72076, Germany|German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf, Duesseldorf, North Rhine Westphalia, 40225, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03437330
|
