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Clinical Trial Details

Trial ID: L5075
Source ID: NCT06227221
Associated Drug: Sorafenib
Title: Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Sorafenib|DRUG: Placebo
Outcome Measures: Primary: The primary endpoint of the study is the change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal, The change from baseline of serum C-peptide (pmol/L), Measured at week 26 | Secondary: Change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal, Change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal tolerance test, Measured at week 52|Change from baseline in glycosylated haemoglobin (HbA1c) levels, Change from baseline in HbA1c (%) levels, Measured at weeks 4, 12, 26 and 52|Change from baseline in insulin dosage, Change from baseline in insulin dosage, including total dose and units per kilogram, Measured at week 26 and 52|The frequency and severity of hypoglycemic events, Number and rate of hypoglycemic events including Grade 1, 2 and 3, Measured at week 26 and 52|Drug safety: gastrointestinal symptoms, rashes, fatigue, bleeding, anemia, infections, cardiovascular events, etc., Number and rate of gastrointestinal symptoms, rashes, fatigue, bleeding, anemia, infections, cardiovascular events, etc., Measured at week 26 and 52
Sponsor/Collaborators: Sponsor: Second Xiangya Hospital of Central South University
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-02
Completion Date: 2028-06
Results First Posted:
Last Update Posted: 2025-01-13
Locations:
URL: https://clinicaltrials.gov/show/NCT06227221