| Trial ID: | L7099 |
| Source ID: | NCT02632747
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02632747/results
|
| Conditions: |
Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Obesity
|
| Interventions: |
DRUG: Empagliflozin|DRUG: Placebo (matching empagliflozin)|DRUG: ramipril
|
| Outcome Measures: |
Primary: Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril., Glomerular filtration rate (GFR) under euglycaemic conditions after 4 weeks of treatment with either empagliflozin added to ramipril or placebo added to ramipril. The pre-specified statistical analysis was not conducted, because data are too sparse in the subgroup of hyperfilterers., At week 4 and at week 12 | Secondary: Filtration Status (Glomerular Filtration Rate (GFR) < 120 mL/Min/1.73m², Yes/no) After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril, Filtration status (Glomerular Filtration Rate (GFR) \< 120 mL/min/1.73m²) after 4 weeks of treatment with either empagliflozin added to ramipril or placebo added to ramipril. Filtration status is defined as whether a patient has normal Filtration status (GFR \< mL/min/1.73m², "yes") or not (GFR ≥ mL/min/1.73m², "no"). The pre-specified statistical analysis was not conducted, because data are too sparse in the subgroup of hyperfilterers., At week 4 and at week 12.
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-05-10
|
| Completion Date: |
2019-07-02
|
| Results First Posted: |
2020-07-24
|
| Last Update Posted: |
2020-07-24
|
| Locations: |
Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02632747
|
