A Phase 2, Randomized, Placebo Controlled Study Investigating the Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus

Trial ID: NCT06227221

Interventional - Phase 2 - Not yet recruiting

The purpose of this study is to investigate the therapeutic effect and safety of Sorafenib in T1DM patients.

Conditions

• Type 1 Diabetes

Interventions

• Sorafenib
• Placebo

Eligibility

Inclusion criteria

• 1. Subjects with written informed consent;
• 2. Age: 18-60 years;
• 3. Diagnosis of T1DM according to ADA criteria within 1 year prior to starting study drug;
• 4. Islet autoantibody positivity (one or more of GADA, IA-2A, ZnT8A);
• 5. Stimulated C-peptide \> 200 pmol/L;
• 6. Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study

Exclusion criteria

• 1. Non-Type 1 Diabetes Mellitus.
• 2. Signs of chronic active infection (e.g., hepatitis, tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes zoster, or toxoplasmosis), or screening laboratory evidence consistent with chronic active infection:
• Positivity for human immunodeficiency virus
• Positive purified protein derivative or interferon-γ release assay suggestive of tuberculosis
• Positivity for hepatitis B surface antigen And acute infections (e.g., respiratory, urinary tract, or gastrointestinal infections) must be resolved before reevaluation;
• 3. Severe hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg, or those requiring the concurrent use of 3 or more antihypertensive medications);
• 4. Previous or current cerebro-cardiovascular diseases:
• Congestive heart failure (NYHA Class III-IV)
• Myocardial infarction
• unstable ischemic heart disease,
• Arrhythmia
• Syncope of cardiac or unknown origin
• Structural defects
• Signs of QT prolongation on electrocardiogram (450 ms in men, 470 ms in women)
• Stroke
• Transient Ischemic Attack
• 5. Hematological conditions:
• Anemia (hemoglobin below 120 g/L in men and 110 g/L in women)
• Leukopenia (\<4000 leukocytes per μL)
• Thrombocytopenia (\<100,000 platelets per μL)
• Neutropenia (\<1500 neutrophils per μL)
• 6. Abnormal coagulation function during the screening period: Prothrombin time (PT) is prolonged beyond the upper limit of normal for 3 seconds and/or activated partial thromboplastin time (APTT) is prolonged beyond the upper limit of normal for 10 seconds;
• 7. Liver and renal dysfunction:
• acute or chronic active hepatitis
• alanine aminotransferase or aspartate aminotransferase \>2·0 times the upper limit of normal persisting for persisting for more than one week
• impaired renal function defined by estimated glomerular filtration rate (according to the CKD-EPI) of \< 60 mL/min/1.73 m2
• 8. History of severe gastrointestinal diseases such as gastrointestinal ulcers, gastrointestinal hemorrhage, pyloric stenosis, gastric bypass surgery, acute or chronic pancreatitis, etc;
• 9. Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study;
• 10. Anticipated ongoing use of diabetes medications other than insulin;
• 11. Known hypersensitivity to sorafenib, or history of severe allergic reactions to other medications (e.g., anaphylaxis, angio-edema, or serious cutaneous drug reactions);
• 12. Use of medications in the last month known to cause an ongoing change in the course of type 1 diabetes or immunological status (e.g., high-dose inhaled, extensive topical, or systemic glucocorticoids);
• 13. Previous treatment with sorefenib or related multikinase inhibitor;
• 14. Concurrent use of medications that affect cytochrome P450 3A4 or use of drugs that interact with sorefenib, leading to altered plasma concentrations of the drugs;
• 15. For men: unwilling to adopt contraception during the whole study period;
• 16. For women:
• Pregnancy or breastfeeding
• Less than 100 days postpartum before enrollment
• Unwilling to defer pregnancy during the 1-year study period
• 17. Known coagulation disorders or use of anticoagulants (e.g., warfarin, rivaroxaban, or low molecular weight heparin);
• 18. Other situations in which the investigator considers it inappropriate to participate in this trial.

Sponsor

Second Xiangya Hospital of Central South University

Source: ClinicalTrials.gov

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