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

NCT06227221 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023ZLNL001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal

  Measured at week 52

• Change from baseline in glycosylated haemoglobin (HbA1c) levels

  Measured at weeks 4, 12, 26 and 52

• Change from baseline in insulin dosage

  Measured at week 26 and 52

• The frequency and severity of hypoglycemic events

  Measured at week 26 and 52

• Drug safety: gastrointestinal symptoms, rashes, fatigue, bleeding, anemia, infections, cardiovascular events, etc.

  Measured at week 26 and 52

Study Arms (2)

Sorafenib

EXPERIMENTAL

Subjects receive sorafenib 400mg once daily. Insulin therapy will be continued as a routine therapy.

Drug: Sorafenib

Placebo

PLACEBO COMPARATOR

Subjects receive placebo 400mg once daily. Insulin therapy will be continued as a routine therapy.

Drug: Placebo

Interventions

Sorafenib DRUG

Subjects receive sorafenib 400mg once daily. Insulin therapy will be continued as a routine therapy.

Sorafenib

Placebo DRUG

Subjects receive placebo 400mg once daily. Insulin therapy will be continued as a routine therapy.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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;
• 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:
• 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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02