
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
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
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'GAD' Trial Information:
Overview
A description of the rationale, design treatments used for the study
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Inclusion and exclusion criteria for the study. Locations & Contacts
Where the study is being conducted, with contact information.
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