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About
The purpose of this study is to investigate the therapeutic effect and safety of Sorafenib in T1DM patients.
Full description
Type 1 Diabetes Mellitus (T1DM) is caused by autoimmune destruction of beta cells in the islet. Insulin has been used as a routine therapy for T1DM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Our preliminary data identified sorafenib as an inhibitor of Th1 differentiation and an indirect inhibitor of JAK2 and found that sorafenib prevented and reversed T1DM in NOD mice by decreasing the accumulation of Th1 cells and the expression of inflammatory cytokines in pancreas. Sorafenib is already in clinical use for renal cell carcinoma, hepatocellular carcinoma and differentiated thyroid cancer. It is hypothesized that sorafenib treatment for 26 weeks will preserve beta cell function in adults with new-onset T1DM. The aim of this study is to investigate the potential of sorafenib on preserving beta cell functions in human T1DM.
Enrollment
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Inclusion criteria
Exclusion criteria
Non-Type 1 Diabetes Mellitus.
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:
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);
Previous or current cerebro-cardiovascular diseases:
Hematological conditions:
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;
Liver and renal dysfunction:
History of severe gastrointestinal diseases such as gastrointestinal ulcers, gastrointestinal hemorrhage, pyloric stenosis, gastric bypass surgery, acute or chronic pancreatitis, etc;
Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study;
Anticipated ongoing use of diabetes medications other than insulin;
Known hypersensitivity to sorafenib, or history of severe allergic reactions to other medications (e.g., anaphylaxis, angio-edema, or serious cutaneous drug reactions);
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);
Previous treatment with sorefenib or related multikinase inhibitor;
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;
For men: unwilling to adopt contraception during the whole study period;
For women:
Known coagulation disorders or use of anticoagulants (e.g., warfarin, rivaroxaban, or low molecular weight heparin);
Other situations in which the investigator considers it inappropriate to participate in this trial.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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