Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM.

Eligibility criteria

Qualifiers

New onset diabetes≥ 200 mg/dl and/or A1c ≥6.5 OR

Worsening glycemic control: requiring insulin per clinician assessment (fasting glucose or average glucose on CGM>20% and /or A1c >0.5% from prior to ICI use ) AND /OR

If Presenting with DKA/HHS: include if within 6 weeks of presentation AND

Must have detectable random c-peptide level 0.2 - 1 ng/mL with blood glucose of 145 mg/dl

Disqualifiers

Participants already on insulin for pre-existing type 1 or type 2 diabetes.

Participants with undetectable c-peptide levels i.e. <0.2 with blood glucose of 145 mg/dl or higher.

For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Trial design

Treatments tested in this trial

  • Infliximab

Treatment groups

14 Participants
are divided into 1 treatment group

Sponsors and collaborators