Can a Rheumatoid Arthritis Drug Prevent Beta Cell Destruction in New Onset Type 1 Diabetes?
Clinical Trial Identifier: NCT02293837
Trial name: TCZ in New-onset Type 1 Diabetes
Diabetes type: Type 1 diabetes.
What is the trial testing? This trial tests Tocilizumab (known by the trade name Actemra or the abbreviation TCZ) for the prevention of type 1 diabetes. TCZ is a drug that targets the immune system. It is currently used in the treatment of other autoimmune diseases, like rheumatoid arthritis, but that has not previously been used for diabetes.
Why does the trial hope to find? This trial is testing TCZ in people who have just developed type 1 diabetes. The researchers hope that TCZ may stop, delay, or decrease the loss of the body’s remaining beta cells.
What is the trial measuring? The trial’s primary outcome measure is the Mixed-Meal Tolerance Test (MMTT)-stimulated mean 2-hour C-peptide AUC. A long name, for sure, but this test is one of the best ways to measure how well the body’s beta cells in the pancreas are producing insulin. The study will also measure A1c and level of insulin use.
Trial Length: Three years.
Trial Location: Ten locations in: California, Florida, Indiana, Minnesota, New York, South Dakota, Tennessee, Texas, and Washington.
Do you qualify? To qualify, volunteers must have been diagnosed with type 1 diabetes within the 100 days prior to screening and test positive for at least one diabetes-related autoantibody. Exclusion criteria include a record of severe heart, lung, kidney, GI, or nerve disease, a serious bacterial, viral, or fungal infection in recent history, or a previous diagnosis of HIV, Hepatitis B or C, or Tuberculosis, among other criteria. A full list of the inclusion and exclusion criteria can be found at the clinicaltrials.gov site.
Where to get more information: For more information about the trial and its enrollment visit the trial’s posting on the clinicaltrials.gov website to find your state’s trial contact.