Letters from Readers-Clinical Trials Underway

| Aug 1, 2002

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 Click Here To View Or Post Comments

Categories: Diabetes, Diabetes, General, Insulin, Type 1 Issues


Take the Diabetes Health Pump Survey
See What's Inside
Read this FREE issue now
For healthcare professionals only

You can view the current or previous issues of Diabetes Health online, in their entirety, anytime you want.
Click Here To View

See if you qualify for our free healthcare professional magazines. Click here to start your application for Pre-Diabetes Health, Diabetes Health Pharmacist and Diabetes Health Professional.

Learn More About the Professional Subscription

Free Diabetes Health e-Newsletter

Latest
Popular
Top Rated
Print | Email | Share | Comments (0)

You May Also Be Interested In...


Click Here To View Or Post Comments

Aug 1, 2002

©1991-2014 Diabetes Health | Home | Privacy | Press | Advertising | Help | Contact Us | Donate | Sitemap

Diabetes Health Medical Disclaimer

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained on or available through this website is for general information purposes only. Opinions expressed here are the opinions of writers, contributors, and commentators, and are not necessarily those of Diabetes Health. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website.