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Clinical Trial Details

Trial ID: L7012
Source ID: NCT04779645
Associated Drug: Remd-477
Title: Effects of GRA in Patients With Type 1
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: REMD-477|DRUG: Placebo
Outcome Measures: Primary: Metabolic Clearance Rate of Insulin, The change from baseline in calculated metabolic clearance rate of insulin as measured by the 2-step Hyperinsulinemic-Euglycemic Clamp., 12-Weeks|Rate of Resting Energy Expenditure (REE), Change from baseline REE as measured by indirect calorimetry., 12-Weeks|Change in Beta-hydroxybutyrate (BHB) Level, The change from baseline in peak BHB production as measured by the insulin withdrawal challenge., 12-Weeks|Change in Free Fatty Acid (FFA) Level, The change from baseline in peak FFA production as measured by the insulin withdrawal challenge., 12-Weeks|Change in mRNA Expression, The change from baseline in gene mRNA expression as measured by adipose and muscle tissue samples., 12-Weeks|Change in Peripheral Macrovascular Vasodilation, The change from baseline in post-stimulus vessel diameter as measured by flow mediated dilation., 12-Weeks|Change in Peripheral Microvascular Vasodilation, The change from baseline in reactive hyperemia index as measured by reactive hyperemia-peripheral arterial tonometry (RH-PAT)., 12-Weeks|Change in Cardiovascular Disease (CVD) Risk Markers., The change in pg/mL from baseline in CVD risk markers (SAA, CRP, VCAM-1 and ICAM-1) as measure by blood samples., 12-Weeks|Change in Cardiovascular Disease (CVD) Risk Markers., The change in ng/mL from baseline in CVD risk markers (Thrombomodulin, ICAM-3, E-Selectin and P-Selectin) as measure by blood samples., 12-Weeks |
Sponsor/Collaborators: Sponsor: University of California, San Diego | Collaborators: REMD Biotherapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-07-31
Completion Date: 2025-03-31
Results First Posted:
Last Update Posted: 2024-01-23
Locations: UC San Diego Altman Clinical & Translational Research Institute, La Jolla, California, 92037, United States
URL: https://clinicaltrials.gov/show/NCT04779645