Trial record 19 of 1635 for:
diabetes | NIH
Effects of Recombinant Human Glutamic Acid Decarboxylase . . .
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Collaborators:
American Diabetes Association
Juvenile Diabetes Research Foundation
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00529399
First received: September 12, 2007
Last updated: January 31, 2011
Last verified: January 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: GAD-Alum Drug: Aluminum hydroxide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Glutamic Acid
Algeldrate
Aluminum
Alum, potassium
Aluminum sulfate anhydrous
Aluminum sulfate
U.S. FDA Resources
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- The primary outcome is the area under the stimulated C-peptide curve (AUC) over tghe first 2 years of a 4-hour mixed meal tolerance test (MMTT). [ Time Frame: Based on MMTT conducted at the two year visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Difference in loss of 2 hr peak C-peptide <0.2 pmol/ml; Mean HbA1c, insulin dose (units/kg), blood glucose ; prevalence of autoantibody positivity ; rates of severe hypoglycemic and adverse events. [ Time Frame: Comparison of values repeated over time per protocol ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 126 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
3 injections of GAD-Alum vaccine
|
Drug: GAD-Alum
Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
Other Name: Diamyd
|
|
Experimental: 2
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
|
Drug: GAD-Alum
Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
Other Name: Diamyd
|
|
Placebo Comparator: 3
3 injections of Aluminum hydroxide alone
|
Drug: Aluminum hydroxide
Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
Other Name: Alhydrogel
|
Detailed Description:
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas called islet cells). As these cells are destroyed, the body's ability to produce insulin decreases. Glutamic acid decarboxylase (GAD) is one of the major autoantigens (a protein that the immune system is reacting to) involved in the autoimmune process underlying T1DM.
GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator. Previous studies have shown that it may slow or prevent autoimmune destruction of pancreatic islet cells by introducing "immune tolerance". By administering excess autoantigen, the body may stop its attack on its own cells that produce insulin. If the immune system's attack can be halted in a patient with recent onset T1DM, than residual insulin secretion may be maintained. This may be beneficial in decreasing acute and long-term diabetic complications as well as improving glucose control.
Eligibility| Ages Eligible for Study: | 3 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529399
Locations
| United States, California | |
| Childrens Hospital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Stanford University | |
| Palo Alto, California, United States, 94305 | |
| University of California-San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States | |
| University of Miami/ Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Childrens Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| University of Texas/Southwestern Medical School | |
| Dallas, Texas, United States, 75390-8858 | |
| United States, Washington | |
| Benaroya Research Institute | |
| Seattle, Washington, United States, 98101 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
American Diabetes Association
Juvenile Diabetes Research Foundation
Investigators
| Principal Investigator: | Diane Wherrett, M.D. | University of Toronto, Hospital for Sick Children |
| Study Chair: | Jay Skyler, M.D. | University of Miami |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ellen Leschek, NIDDK |
| ClinicalTrials.gov Identifier: | NCT00529399 History of Changes |
| Other Study ID Numbers: | GAD65 (IND) |
| Study First Received: | September 12, 2007 |
| Last Updated: | January 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
treatment of type 1 diabetes new onset type 1 diabetes juvenile diabetes diabetes mellitus Type 1 diabetes TrialNet immune tolerance immunotherapy |
antigen-specific tolerance vaccine induced tolerance Beta-cell function T-cells DPT-1 T1D TrialNet |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Aluminum Hydroxide |
Aluminum sulfate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013