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

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT00529399

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

145

Starts

2009-02-01

Expected to finish

2012-05-01

Last updated by the study team

2020-05-07

Who can join

Age: 3 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Childrens Hospital of Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California-San Francisco — San Francisco, California, United States
• Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami/ Miller School of Medicine — Miami, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Columbia University — New York, New York, United States
• Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas/Southwestern Medical School — Dallas, Texas, United States
• Benaroya Research Institute — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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