| Trial ID: | L1789 |
| Source ID: | NCT05696366
|
| Associated Drug: |
Sotagliflozin
|
| Title: |
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
|
| Acronym: |
SOTA
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Sotagliflozin|DRUG: Volagidemab
|
| Outcome Measures: |
Primary: Change in HbA1c, Quantify the effects of combination adjunctive therapy on glycemic control. Though it has limitations, the HbA1c remains the gold standard measurement of glycemic control in diabetes., 12 weeks | Secondary: Change in percent time in range (70-180 mg/dl) by CGM, Continuous glucose monitoring (CGM) provides much more granular data relating to glucose trends and time spent in target glucose range, above range (hyperglycemia), and below range (hypoglycemia)., 12 weeks|Change in subject self reported ambulatory insulin dosing, Change in ambulatory insulin dosing as shown through subject insulin diary., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Diego | Collaborators: Lexicon Pharmaceuticals|Breakthrough T1D
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-09-09
|
| Completion Date: |
2028-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-04
|
| Locations: |
UC San Diego Altman Clinical & Translational Research Institute, La Jolla, California, 92037, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05696366
|
