Clinical Trial Details
| Trial ID: | L5937 |
| Source ID: | NCT04061200 |
| Associated Drug: | Semaglutide, 1.34 Mg/Ml |
| Title: | Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria |
| Acronym: | EmpaSema |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes With Renal Manifestations |
| Interventions: | DRUG: Semaglutide, 1.34 mg/mL|OTHER: Placebo, 1,34 mg/mL|DRUG: Empagliflozin 25 MG |
| Outcome Measures: | Primary: Albuminuria, Change in albuminuria, From randomisation to week 52 | Secondary: Hba1c, Change in Hba1c, From randomisation to week 52|GFR, Change in measured kidney function (GFR), From randomisation to week 52|24 hour blood pressure, Change in 24 hour blood pressure, From randomisation to week 52|Vasoactive hormones, Change in vasoactive hormones (o Plasma renin concentration, plasma renin activity, angiotensin I, angiotensin II, aldosterone, copeptin), From randomisation to week 52|Inflammatory and endothelial biomarkers, Change in inflammatory and endothelial biomarkers (Von Willebrand factor, sVCAM-1, sICAM-1, E-selectin, b-leucocytes, s-CRP, IL-6, osteopontin, TNF-α), From randomisation to week 52 |
| Sponsor/Collaborators: | Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 80 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2019-11-01 |
| Completion Date: | 2021-08-01 |
| Results First Posted: | |
| Last Update Posted: | 2019-08-19 |
| Locations: | Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark |
| URL: | https://clinicaltrials.gov/show/NCT04061200 |
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