A drug used to help kidney transplant patients avoid rejection preserved insulin production in newly diagnosed type 1 diabetes patients in a recent study.
Researchers at the University of Florida and 14 other TrialNet-associated institutions recently led a study to see if the drug thymoglobulin could slow insulin loss, either on its own or with another drug. The researchers, who report it was effective for people with type 1 diabetes, presented their findings Monday at the American Diabetes Association Scientific Sessions, and expect to publish them in the journal Diabetes Care.
The data presented at the conference represents early findings of the two-year clinical trial, which wraps up in August. Final findings are expected next year.
"It gives us hope that we really are on the right path to preventing and reversing type 1 diabetes," lead author Dr. Michael Haller, a UF Diabetes Institute researcher, said in a press release. "We still have a long way to go but this is a remarkable success that we should celebrate. These findings remind us and our patients that we are indeed making progress."
Type 1 diabetes is an autoimmune disease affecting about 1.25 million American children and adults. For patients with the disease, islet cells in the pancreas that produce insulin are attacked by the body's immune system, preventing normal regulation of sugar levels in the blood.
After finding that thymoglobulin, or ATG, was effective with animals, the researchers enrolled 89 people in the trial between age 12 and 45 who had been diagnosed with type 1 diabetes in the previous 100 days. Participants were then divided into three groups, with one group receiving a low dose of ATG, one group receiving ATG and the drug pegylated GCSF, and the third group receiving a placebo.
In one year, insulin production had increased in those given low-dose ATG compared with the placebo. The drug also significantly reduced hemoglobin A1C levels, which is a measure of average blood sugar levels.
The combination treatment did not, however, show efficacy beyond patients receiving the ATG alone.
Researchers found ATG works by killing "rogue" immune cells -- targeting white blood cells that attack and kill insulin-producing beta cells instead of attacking viruses or bacteria.
Side effects included a few minutes of muscle soreness, nausea or headache during the intravenous infusion, and two-thirds of patients experienced two to three days of flu-like symptoms for about a week.
"We are excited about these important findings and the potential to conduct additional studies to test ATG even earlier in the disease process, prior to symptoms and clinical diagnosis, as well as later in the disease process for patients with more established type 1 diabetes," Haller said.
Haller said the drug is not a permanent cure or a way to prevent the onset of type 1 diabetes, but it can help people with type 1 diabetes control their sugar levels. Current treatment options are limited to increasing insulin from injections or a continuous pump.
While the drug may not last forever, Haller said it could be possible to extend its efficacy by re-treating patients with the drug. He also plans to study whether ATG can prevent diabetes in people with biological markers for the disease.
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