| Trial ID: | L3755 |
| Source ID: | NCT05035368
|
| Associated Drug: |
Ladarixin
|
| Title: |
Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type I Diabetes
|
| Interventions: |
DRUG: Ladarixin|OTHER: Placebo
|
| Outcome Measures: |
Primary: The mean difference in glucose infusion rate (GIR) from baseline, The glucose infusion rate (GIR) is a measure of the rate at which the patient receives intravenous administration of dextrose, which increases blood sugar levels. GIR is expressed in mg per kilogram body weight per minute (mg/Kg/min)., Week 25 of each treatment period (visits 4 and 8) | Secondary: Change from baseline of HbA1c levels, In this study glycated hemoglobin (HbA1c) must be between 7.5%-10.0%, inclusive, as per results of screening laboratory measurement., Week 25/26 (no later than 10 days after the last IMP dose) of each treatment period (visits 5 and 9)|Change in average (previous 3 days) daily insulin requirements, In this study insulin requirement is calculated as IU/kg/day averaged over the previous 3 days., Week 25/26 (no later than 10 days after the last IMP dose) of each treatment period (visits 5 and 9)
|
| Sponsor/Collaborators: |
Sponsor: Dompé Farmaceutici S.p.A
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-09-30
|
| Completion Date: |
2023-06
|
| Results First Posted: |
|
| Last Update Posted: |
2023-12-22
|
| Locations: |
Institute of Cellular Therapeutics Allegheny Health Network, Pittsburgh, Pennsylvania, 15212, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05035368
|
