Not Yet RecruitingPhase 2

Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus

10 participantsStarted 2026-02

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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;

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

Timeframe: Measured at week 26

NCT IDNCT06227221

SponsorSecond Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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;