| Trial ID: | L5028 |
| Source ID: | NCT05368402
|
| Associated Drug: |
Ladarixin
|
| Title: |
Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes.
|
| Acronym: |
CONSERVA
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05368402/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Ladarixin|OTHER: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With an HbA1c Reduction From Baseline of ≥0.50% (Absolute Difference) Without Episodes of Severe Hypoglycemia., Please note that this outcome is meant to express the "count" (number + %) of participants. Please also note that because of the low recruitment rate (out of the 24 participants screened, only 2 participants were enrolled, 1 in the ladarixin group and 1 in the placebo group), it was not possible to have a consistent sample size for any formal statistical analyses, accordingly no efficacy evaluation was conducted on the two randomized subjects' data. The low recruitment rate led the Sponsor decide to close enrollment on 04th August 2023 and thus to early terminate the study., At Visit 4 (week 27/28) | Secondary: Number of Patients With Treatment Emergent Adverse Events (TEAEs) of Any Kind From the Beginning of Study Treatment to up to the End of Study Participation, Number of Patients With Treatment Emergent Adverse Events (TEAEs) of Any Kind From the Beginning of Study Treatment administration to up to the End of Study Participation was reported. AE= any untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. serious AE (SAE)= any adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. non serious AE(nsAE)= any adverse drug experience associated with the use of the Product in humans, whether or not considered drug-related, which is not a Serious Adverse Event., Throughout the study, up to week 26 (day 182)
|
| Sponsor/Collaborators: |
Sponsor: Dompé Farmaceutici S.p.A
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
3
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-09-14
|
| Completion Date: |
2023-09-18
|
| Results First Posted: |
2025-02-03
|
| Last Update Posted: |
2025-02-03
|
| Locations: |
Ospedale F. Spaziani Frosinone, Frosinone, 03100, Italy|Università Campus Bio-Medico di Roma (UCBM) Policlinico Universitario, Rome, 00128, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT05368402
|
