Infliximab for Diabetes

Overseen By Priyanka C Iyer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Steroids, Investigational agents

Disqualifiers: Type 1 diabetes, Heart failure, TB, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug infliximab, a monoclonal antibody, can safely help individuals with a specific type of diabetes called CIADM stop needing insulin shots. The trial seeks patients who have recently developed diabetes after receiving certain immune therapies and are struggling to control their blood sugar. Suitable candidates include those with a new diabetes diagnosis and high blood sugar levels or those with worsening blood sugar control who meet other specific health criteria. The goal is to assess whether infliximab can make diabetes management easier and safer for these patients. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform diabetes management.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that any concomitant drugs defined in section 5.7 will be excluded, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that infliximab is likely to be safe for humans?

Studies have shown that infliximab is generally safe, but some risks exist. In one study, 39.2% of patients experienced side effects, and 14.9% had serious ones. Additionally, a report from the Mayo Clinic noted a 1% fatality rate with infliximab use.

While these numbers might seem concerning, infliximab is already approved and used for other conditions. It has effectively reduced inflammation and improved insulin resistance in some patients. This background provides some confidence in its safety, but joining a clinical trial means understanding and accepting these risks. Always consult a healthcare provider to determine if participation is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetes focus on managing blood sugar levels through insulin or other glucose-lowering medications. However, infliximab is unique because it's an anti-inflammatory drug that's typically used to treat autoimmune conditions like rheumatoid arthritis. Researchers are excited about infliximab because it targets inflammation, which is believed to play a role in diabetes. By reducing inflammation, infliximab could potentially improve insulin sensitivity and help manage diabetes in a novel way. This approach could offer a new pathway for treatment beyond the traditional focus on blood sugar levels alone.

What evidence suggests that infliximab might be an effective treatment for diabetes?

Research has shown that infliximab, the treatment under study in this trial, might help manage diabetes by protecting insulin-producing cells. In two cases, patients taking infliximab maintained stable levels of C-peptide, indicating insulin production and suggesting it might slow cell damage. Another study examined blood sugar levels and insulin use, showing that infliximab could help control blood sugar without causing major drops. Although infliximab is primarily used for other health issues, these findings suggest it might help some diabetic patients rely less on insulin. ^{1 2 6 7 8}

Who Is on the Research Team?

Priyanka C Iyer, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who have developed diabetes after receiving checkpoint inhibitor therapy, a type of cancer treatment. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.

Inclusion Criteria

Approved methods of birth control

Ability to understand and sign a written informed consent document

I was referred for a new diabetes diagnosis after my last immune therapy dose.

Exclusion Criteria

Participants with undetectable c-peptide levels

Participants receiving other investigational agents for CIADM

History of allergic reactions or hypersensitivity to compounds similar to Infliximab

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive infliximab to assess its efficacy in reversing insulin dependence in CIADM

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Infliximab

Trial Overview The study is testing whether infliximab, an anti-inflammatory medication, can reverse insulin dependence in patients with diabetes caused by checkpoint inhibitor therapy. It's a pilot study to assess safety and effectiveness.

How Is the Trial Designed?

Group I: Pilot Study Treatment wiith Infliximab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12634352/

Immune checkpoint inhibitor-induced diabetes can ... Case 1 suggests that C-peptide maintenance through infliximab results in improved control without significant hypoglycemia while on insulin.

2. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A1411

1274 Infliximab for decompensated diabetes following ... We assessed efficacy of this therapy by monitoring blood glucoses with a continuous glucose monitor (CGM), total daily dose of insulin, c- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11550226/

Real-World Safety and Effectiveness of Infliximab in 255 ... These results confirmed the safety and effectiveness of infliximab in clinical practice in 255 patients with intestinal BD, NBD, and VBD. There were no new ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2665991323003417

Clinical consequences of infliximab immunogenicity and ... Antidrug antibodies were detected in 147 (24%) patients. Remission at week 30 occurred in 25 (35%) of 72 patients with antidrug antibodies and 180 (54%) of 335 ...

5. researchgate.net researchgate.net/publication/397383351_Immune_checkpoint_inhibitor-induced_diabetes_can_potentially_be_effectively_treated_with_infliximab_a_case_report_of_two_patients

(PDF) Immune checkpoint inhibitor-induced diabetes can ... We present two cases in which infliximab treatment appeared to halt beta-cell destruction, as evidenced by maintenance of C-peptide levels, as ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1568997210000042

Review Infliximab and insulin resistance Literature evidences show that infliximab administration can improve insulin resistance in non-diabetic rheumatic patients. The clinical relevance of this ...

7. jwatch.org jwatch.org/jg200406290000007/2004/06/29/infliximab-safety-experience-population-based

Infliximab Safety Experience in a Population-Based Cohort A recent Mayo Clinic safety report suggested that use of infliximab was associated with a 1% fatality rate (Journal Watch Gastroenterology ...

8. ajmc.com ajmc.com/view/disease-activity-safety-remain-following-switch-from-infliximab-biosimilar-to-originator-in-ibd

Disease Activity, Safety Remain Following Switch From ... Switching between infliximab biosimilar SB2 and the reference product did not affect clinical disease activity or safety in IBD patients. · No ...