| Trial ID: | L6866 |
| Source ID: | NCT04545411
|
| Associated Drug: |
Dapagliflozin 10 Mg [Farxiga]
|
| Title: |
Combination GRA and SGLT-2i Treatment in Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Dapagliflozin 10 MG [Farxiga]|DRUG: REMD-477|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Beta-hydroxybutyrate (BHB) Level, The change from baseline in peak BHB production as measured by the insulin withdrawal challenge., 4-Weeks|Change in Glycemic Control, The change from baseline glycemic control as measured by a 2-week average of CGM "time-in-range"., 4-Weeks|Change in Glycemic Control, The change from baseline glycemic control as measured by HbA1c., 4-Weeks|Change in Vascular Endothelial Function, The change from baseline in vascular endothelial function as measured by flow mediated dilation (brachial artery diameter)., 4-Weeks|Change in Vascular Endothelial Function, The change from baseline in vascular endothelial function as measured by reactive hyperemia-peripheral arterial tonometry (reactive hyperemia index)., 4-Weeks |
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Diego | Collaborators: REMD Biotherapeutics, Inc.|Juvenile Diabetes Research Foundation|The Leona M. and Harry B. Helmsley Charitable Trust
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2021-02-22
|
| Completion Date: |
2022-10-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-01-23
|
| Locations: |
UC San Diego Altman Clinical & Translational Research Institute, La Jolla, California, 92037, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04545411
|
