Can a Cancer Drug Help Delay the Onset of Type 1 Diabetes?

Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page. 

Twitter Summary: @JDRF funded study tests cancer drug #Gleevec in recently diagnosed ppl w/ #T1D to see if it slows destruction of #insulin producing cells

Clinical Trial Identifier: NCT01781975

Trial name: Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus

Diabetes type: Type 1 diabetes.

What it’s testing: The trial is examining how the cancer drug imatinib (or Gleevec) could be used to stop or delay the autoimmune response that attacks insulin producing beta cells in people newly diagnosed with type 1 diabetes. Participants in the trial will be randomized to either receive Gleevec or a placebo.

Gleevec works by inhibiting a group of enzymes called “tyrosine kinases.” These enzymes serve many functions, including roles in cell growth and proliferation and in the body’s immune system. For type 1 diabetes, it’s possible that some of these enzymes are involved in the autoimmune response that destroys beta cells in the pancreas.  Gleevec may affect various parts of the immune system, including how T cells (the primary arm of the immune system responsible for beta cell destruction) are targeted to beta cells.  Gleevec may have other benefits as well, as suggested in animal studies and in other studies in humans, including reducing destruction of beta cells and making those treated with the drug more sensitive to insulin.  Notably, a related approach with a similar medication is now an FDA approved treatment for rheumatoid arthritis, another autoimmune disease. 

What the trial is measuring: The primary outcome being evaluated in this trial is how beta cell function changes over time.  As in related studies, the investigators will evaluate how much insulin participants can make at the start of the study, and assess how this changes over time in those treated with Gleevec compared to those receiving a placebo. To do this, the trial investigators will measure a metabolite of insulin made by the body, called C-peptide. C-peptide is produced by beta cells in the pancreas at the same time as insulin, so the levels of C-peptide correlate directly to the body’s insulin production.

In addition to C-peptide levels, the researchers will examine A1c, insulin dose changes throughout the trial, and the number of severe hypoglycemic events. 

Why this is new/important: This study offers a new approach to fighting off the body’s autoimmune attack against beta cells. This intervention, if successful, might allow people with newly onset type 1 diabetes to take less insulin for a longer period of time or even have a long-term remission. Ultimately, this could help lead to better blood sugar control and less risk of complications down the road.  If successful in new onset type 1 diabetes, it may also be helpful for those at risk for diabetes. 

Trial Length: Two years. In the first year of the trial, participants will have a two-week and four-week check-in, followed by a once-monthly check-in after that. For the second year, participants will check-in every six months.

Trial Location: The trial has sites in California, Colorado, Georgia, Indiana, Iowa, Massachusetts, Pennsylvania, Texas, and Australia. For more information on getting involved, please see this webpage.

Do you qualify? To qualify for this study, participants must be between 18 to 45 years old and have been diagnosed with type 1 diabetes in the last 100 days, among other criteria. Exclusion criteria include a history of significant heart disease, any sign of significant chronic infection (e.g. tuberculosis, HIV, etc.), ongoing use of diabetes medications other than insulin (e.g. GLP-1 agonists, amylin, etc.), evidence of liver or renal dysfunction, and more. For a full list of eligibility criteria, please see this page.

Where to get more information: To get more information about this trial’s details and how to participate, please see the clinicaltrials.gov page or the trial’s user-friendly webpage to get more information. -AJW/MRV