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Type 1 DiabetesPhase 2NCT06227221

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

A Phase 2 study testing Sorafenib in people with Type 1 Diabetes, run by Second Xiangya Hospital of Central South University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Sorafenib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
No sites listed yet
Study dates
Feb 2026to Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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);
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  • 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
  • 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)
  • 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:
  • 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
  • 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:
  • Pregnancy or breastfeeding
  • Less than 100 days postpartum before enrollment
  • Unwilling to defer pregnancy during the 1-year study period
  • 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.

About this study

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

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

Read the detailed 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.

Conditions
Type 1 Diabetes
Being tested
Sorafenib, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

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

  • PlaceboDrug

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

Study groups in NCT06227221
Study groupRoleWhat they receive
SorafenibExperimentalSubjects receive sorafenib 400mg once daily. Insulin therapy will be continued as a routine therapy.
Receives: Drug: Sorafenib
PlaceboPlacebo comparatorSubjects receive placebo 400mg once daily. Insulin therapy will be continued as a routine therapy.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured at week 26

Secondary outcomes (5)

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

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

    Measured: Measured at week 52

  2. Change from baseline in glycosylated haemoglobin (HbA1c) levels

    Change from baseline in HbA1c (%) levels

    Measured: Measured at weeks 4, 12, 26 and 52

  3. Change from baseline in insulin dosage

    Change from baseline in insulin dosage, including total dose and units per kilogram

    Measured: Measured at week 26 and 52

  4. The frequency and severity of hypoglycemic events

    Number and rate of hypoglycemic events including Grade 1, 2 and 3

    Measured: Measured at week 26 and 52

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

    Number and rate of gastrointestinal symptoms, rashes, fatigue, bleeding, anemia, infections, cardiovascular events, etc.

    Measured: Measured at week 26 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study startFeb 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227221
Sponsor's protocol ID
2023ZLNL001
Status last verified
Feb 2026
First submitted
17 Jan 2024
Last updated
12 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib in people with Type 1 Diabetes, run by Second Xiangya Hospital of Central South University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Measured at week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06227221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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