Multicenter phase 1 and 2 clinical trials are now underway for a new drug that has been shown to either maintain or improve insulin production during the first year following diagnosis for nine of 12 subjects with new-onset type 1 diabetes. Only two of 12 control subjects, who did not receive the drug, maintained or improved their insulin production.
In the initial clinical trial, newly diagnosed subjects with type 1 diabetes received the drug-called hOKT3g1, or Ala-Ala-for two weeks and were then followed for one year.
Ala-Ala appears to work by deactivating T-cells that are primed to destroy the insulin-producing beta cells in the pancreas, say researchers at the University of California, San Francisco, and Columbia University in New York City.
“We’re trying to get about eighty people enrolled” in the phase 2 clinical trials, Stephen E. Gitelman, MD, of UC San Francisco told DIABETES HEALTH.
Clinical trials are taking place at several institutions, including Columbia University; the Barbara Davis Center for Childhood Diabetes; the University of Colorado; the Virginia Mason Medical Center; the University of Florida; the University of California, San Francisco; and the University of Washington.
Participants must be between the ages of 7 and 20, weigh at least 57 pounds, enroll within six weeks following a type 1 diagnosis and begin treatment within eight weeks of diagnosis.
Participants will “receive the drug for three courses at six-month intervals,” Dr. Gitelman explains, adding that a course of treatment consists of a 15-minute IV infusion of Ala-Ala each day for 12 days. Subjects will be randomly assigned to receive either Ala-Ala (two-thirds of the participants) or a placebo (one-third of the participants).
Dr. Gitelman notes that side effects are minor and may consist of mild viral-like symptoms and a rash, which can be controlled with an anti-inflammatory medication or Benadryl if the rash is itchy.
“We’re excited about it,” says Dr. Gitelman. “The people in the first phase looked much better after one year.”
He added that researchers don’t yet know how long the beta-cell-
saving effects of Ala-Ala will last.
For more information about the upcoming clinical trials, log on to www.immunetolerance.org. Updates will be posted as more information becomes available.
– J. Chait