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Clinical Research Trials

AbATE : A Trial for Patients Recently Diagnosed with Type 1 Diabetes

What is the AbATE trial?
The AbATE trial is a phase II clinical trial of a new drug called hOKT3y (Ala-Ala), which has been shown in preliminary studies to slow the progression of type 1 diabetes in newly diagnosed patients.  The AbATE study will test whether two short treatments of hOKT3y (Ala-Ala) can stop type 1 diabetes from progressing further after diagnosis.
Who can participate in the trial?
Individuals aged 8-30 who:

  • Have been diagnosed with type 1 diabetes within the past 6 weeks
  • Weigh at least 55lbs. (25 kg)
  • Are NOT currently pregnant or breastfeeding
  • Do not have asthma, and
  • Have not participated in another clinical trial within the past 6 weeks

What is known about the effects of hOKT3y (Ala-Ala)?
A preliminary study showed that hOKT3y (ala-ala) given to newly diagnosed type 1 diabetes could preserve beta cell function and decrease the insulin dose required compared to patients receiving standard diabetes management.  The effects of the drug lasted for at least two years.
Can type 1 diabetes be stopped?
At present there are no FDA-approved medications that halt the immune destruction of beta cells in those with type 1 diabetes.  Researchers, however, are investigating new treatments designed to preserve the 15-40% of healthy beta cells that generally remain at the time of diagnosis.  If successful, it is believed that a prolonged remission period would occur that would decrease or eliminate the need for insulin injections and ultimately lead to fewer secondary complications of type 1 diabetes.

For more information contact:
Meyer Belzer
303-724-6758  
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado
http://www.abatetrial.org/faqs.html