| Trial ID: | L5543 |
| Source ID: | NCT03877406
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
Effect of Empagliflozin on Body Composition and Ketones
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Fat; Intolerance, Pancreas
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Hypoglycemics Oral
|
| Outcome Measures: |
Primary: HbA1c, glycemic control, 6 months | Secondary: Biochemical parameters, Ketone body concentration, 6 months|Body weight, Weight change, 6 months|Body fat, fat change, 6 months|Systolic and diastolic blood pressures, blood pressure change, 6 months|Lipid profile, Triglyceride, 6 months|Insulin resistance, HOMA-IR, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-08-01
|
| Completion Date: |
2023-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-14
|
| Locations: |
Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT03877406
|
