Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: American Diabetes Association; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Juvenile Diabetes Research Foundation; National Center for Research Resources (NCRR); National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aluminum Hydroxide; Aluminum sulfate; Vaccines

Criteria

Inclusion Criteria:

• Age 3 to 45 years - Insulin dependent type 1-diabetes mellitus diagnosed within the previous 3 months

• Stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted 3 weeks from diagnosis of diabetes

• Presence of GAD65 antibodies

• 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

• Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration

Exclusion Criteria:

• Immunodeficiency or clinically significant chronic lymphopenia

• Active infection

• Positive PPD test result

• Pregnant or lactating or anticipating becoming pregnant for 24 months following first injection

• Ongoing use of medications known to influence glucose tolerance

• Require use of systemic immunosuppressant(s)

• Serologic evidence of current or past HIV, Hep B, or Hep C infection

• History of malignancies

• 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

• Complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological, or clinically significant blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia)

• History of epilepsy, head trauma or cerebrovascular accident or clinical

• History of alcohol or drug abuse