| Trial ID: | L5475 |
| Source ID: | NCT03744975
|
| Associated Drug: |
Lcz 696
|
| Title: |
PDD in Type 2 Diabetes W/wo Diastolic Dysfunction
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Diastolic Dysfunction
|
| Interventions: |
DRUG: LCZ 696|DRUG: Placebos
|
| Outcome Measures: |
Primary: Plasma cGMP Response, The change in plasma cGMP levels from baseline to after volume expansion DM with PDD versus non-PDD, 3 months | Secondary: Renal response, The composite endpoint consisting of sodium excretion, GFR, urinary cGMP and diastolic function change from baseline to volume expansion in Type 2 DM with PDD versus non-PDD, 3months
|
| Sponsor/Collaborators: |
Sponsor: Mayo Clinic
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-05-01
|
| Completion Date: |
2025-01-21
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-07
|
| Locations: |
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03744975
|
