Clinical Trials Now Enrolling Volunteers
Trials near you
About volunteering for clinical trials
About type 1 diabetes
About the Immune Tolerance Network
HOME ITN and Study Contacts


Inclusion Criteria:
To qualify for participation in this study, individuals must meet the following minimum criteria:

  • Age 16 to 45 years (later on the study plans to enroll younger teens and children)
  • Insulin dependent type 1-diabetes mellitus diagnosed within the previous 3 months
  • At least one month from last immunization
  • Willing to comply with intensive diabetes management
  • If participant is a woman with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test
  • Must weigh at least 25 kg at study entry
  • Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration

Exclusion Criteria:
Individuals meeting any of the criteria below will not be eligible to participate in the study. Additional exclusion criteria may apply.

  • Immunodeficiency or clinically significant chronic lymphopenia
  • Pregnant or lactating or anticipating becoming pregnant for 24 months following first injection
  • Serologic evidence of current or past HIV, Hep B, or Hep C infection
  • Ongoing use of non-insulin pharmaceuticals to affect glycemic control
  • Participation in another clinical trial with a new chemical entity within the past 3 months
  • History of epilepsy, head trauma or cerebrovascular accident or clinical
  • History of alcohol or drug abuse

 

 

 

 

'GAD' Trial Information:

Overview
A description of the rationale, design treatments used for the study

>> Eligibility <<
Inclusion and exclusion criteria for the study.

Locations & Contacts
Where the study is being conducted, with contact information.