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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06227221
Other study ID # 2023ZLNL001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2024
Est. completion date December 2026

Study information

Verified date January 2024
Source Second Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


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Study Design


Intervention

Drug:
Sorafenib
Subjects receive sorafenib 400mg once daily. Insulin therapy will be continued as a routine therapy.
Placebo
Subjects receive placebo 400mg once daily. Insulin therapy will be continued as a routine therapy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Xiangya Hospital of Central South University

Outcome

Type Measure Description Time frame Safety issue
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 Measured at week 26
Secondary Change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal Measured at week 52
Secondary Change from baseline in glycosylated haemoglobin (HbA1c) levels Measured at weeks 4, 12, 26 and 52
Secondary Change from baseline in insulin dosage Measured at week 26 and 52
Secondary The frequency and severity of hypoglycemic events Measured at week 26 and 52
Secondary Drug safety: gastrointestinal symptoms, rashes, fatigue, bleeding, anemia, infections, cardiovascular events, etc. Measured at week 26 and 52
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