Infliximab for Diabetes
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive infliximab to assess its efficacy in reversing insulin dependence in CIADM
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
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.
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- ...
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 ...
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 ...
(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 ...
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 ...
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 ...
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 ...
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