Type 1 Diabetes MellitusPhase 2TN08NCT00529399
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
A Phase 2 study testing GAD-Alum, GAD-Alum and Aluminum hydroxide and Aluminum hydroxide in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- GAD-Alum, GAD-Alum and Aluminum hydroxide and Aluminum hydroxide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Feb 2009to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Texas/Southwestern Medical School
Dallas, Texas, 75390-8858
University of Florida
Gainesville, Florida
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
University of Miami/ Miller School of Medicine
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Yale University School of Medicine
New Haven, Connecticut, 06520
Columbia University
New York, New York, 10032
Stanford University
Palo Alto, California, 94305
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California-San Francisco
San Francisco, California, 94143
Benaroya Research Institute
Seattle, Washington, 98101
About this study
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
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).
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- GAD-Alum, GAD-Alum and Aluminum hydroxide, Aluminum hydroxide
- Keywords
- immune tolerance, immunotherapy, antigen-specific tolerance, vaccine induced tolerance, Beta-cell function, T-cells, DPT-1, treatment of type 1 diabetes, new onset type 1 diabetes, juvenile diabetes, T1D, diabetes mellitus, Type 1 diabetes TrialNet, TrialNet
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAD-AlumDrug
Also called Diamyd
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.
GAD-Alum and Aluminum hydroxideDrug
Also called Diamyd
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.
Aluminum hydroxideDrug
Also called Alhydrogel
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 injections of GAD-Alum vaccine Receives: Drug: GAD-Alum |
| 2 | Experimental | 2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone Receives: Drug: GAD-Alum and Aluminum hydroxide |
| 3 | Placebo comparator | 3 injections of Aluminum hydroxide alone Receives: Drug: Aluminum hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
Measured: Based on mixed meal tolerance test (MMTT) conducted at the one year visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Center for Research Resources (NCRR), American Diabetes Association, Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Diane Wherrett, M.D., Principal investigator, University of Toronto, Hospital for Sick ChildrenJay Skyler, M.D., Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529399
- Sponsor's protocol ID
- TN08 GAD65
- Other IDs
- U01DK061055, UC4DK097835
- Acronym
- TN08
- Status last verified
- Apr 2020
- First submitted
- 12 Sep 2007
- Last updated
- 7 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/tn08-gad-new-onset/?query=tn08
Publications
Atkinson MA, Eisenbarth GS. Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet. 2001 Jul 21;358(9277):221-9. doi: 10.1016/S0140-6736(01)05415-0.
PubMed 11476858Pleau JM, Fernandez-Saravia F, Esling A, Homo-Delarche F, Dardenne M. Prevention of autoimmune diabetes in nonobese diabetic female mice by treatment with recombinant glutamic acid decarboxylase (GAD 65). Clin Immunol Immunopathol. 1995 Jul;76(1 Pt 1):90-5. doi: 10.1006/clin.1995.1092.
PubMed 7606872Tian J, Clare-Salzler M, Herschenfeld A, Middleton B, Newman D, Mueller R, Arita S, Evans C, Atkinson MA, Mullen Y, Sarvetnick N, Tobin AJ, Lehmann PV, Kaufman DL. Modulating autoimmune responses to GAD inhibits disease progression and prolongs islet graft survival in diabetes-prone mice. Nat Med. 1996 Dec;2(12):1348-53. doi: 10.1038/nm1296-1348.
PubMed 8946834Tisch R, Liblau RS, Yang XD, Liblau P, McDevitt HO. Induction of GAD65-specific regulatory T-cells inhibits ongoing autoimmune diabetes in nonobese diabetic mice. Diabetes. 1998 Jun;47(6):894-9. doi: 10.2337/diabetes.47.6.894.
PubMed 9604865Tisch R, Wang B, Weaver DJ, Liu B, Bui T, Arthos J, Serreze DV. Antigen-specific mediated suppression of beta cell autoimmunity by plasmid DNA vaccination. J Immunol. 2001 Feb 1;166(3):2122-32. doi: 10.4049/jimmunol.166.3.2122.
PubMed 11160264Jun HS, Chung YH, Han J, Kim A, Yoo SS, Sherwin RS, Yoon JW. Prevention of autoimmune diabetes by immunogene therapy using recombinant vaccinia virus expressing glutamic acid decarboxylase. Diabetologia. 2002 May;45(5):668-76. doi: 10.1007/s00125-002-0806-9. Epub 2002 Apr 4.
PubMed 12107747Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
PubMed 21714999
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00529399
- Acronym / sponsor ID
- TN08 / TN08 GAD65
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- immune tolerance, immunotherapy, antigen-specific tolerance, vaccine induced tolerance, Beta-cell function, T-cells, DPT-1, treatment of type 1 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Center for Research Resources (NCRR), American Diabetes Association, Juvenile Diabetes Research Foundation
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 7 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GAD-Alum3 injections of GAD-Alum vaccine |
| 2 | Experimental | Drug: GAD-Alum and Aluminum hydroxide2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone |
| 3 | Placebo comparator | Drug: Aluminum hydroxide3 injections of Aluminum hydroxide alone |
Who may qualify
- Ages
- 3 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAD-AlumAlso: DiamydParticipants 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. | Drug | 1 |
| GAD-Alum and Aluminum hydroxideAlso: DiamydParticipants 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. | Drug | 2 |
| Aluminum hydroxideAlso: AlhydrogelParticipants 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. | Drug | 3 |
Primary outcome
The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit
Time frame: Based on mixed meal tolerance test (MMTT) conducted at the one year visit
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11476858Atkinson MA, Eisenbarth GS. Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet. 2001 Jul 21;358(9277):221-9. doi: 10.1016/S0140-6736(01)05415-0.
- Background: PubMed 7606872Pleau JM, Fernandez-Saravia F, Esling A, Homo-Delarche F, Dardenne M. Prevention of autoimmune diabetes in nonobese diabetic female mice by treatment with recombinant glutamic acid decarboxylase (GAD 65). Clin Immunol Immunopathol. 1995 Jul;76(1 Pt 1):90-5. doi: 10.1006/clin.1995.1092.
- Background: PubMed 8946834Tian J, Clare-Salzler M, Herschenfeld A, Middleton B, Newman D, Mueller R, Arita S, Evans C, Atkinson MA, Mullen Y, Sarvetnick N, Tobin AJ, Lehmann PV, Kaufman DL. Modulating autoimmune responses to GAD inhibits disease progression and prolongs islet graft survival in diabetes-prone mice. Nat Med. 1996 Dec;2(12):1348-53. doi: 10.1038/nm1296-1348.
- Background: PubMed 9604865Tisch R, Liblau RS, Yang XD, Liblau P, McDevitt HO. Induction of GAD65-specific regulatory T-cells inhibits ongoing autoimmune diabetes in nonobese diabetic mice. Diabetes. 1998 Jun;47(6):894-9. doi: 10.2337/diabetes.47.6.894.
- Background: PubMed 11160264Tisch R, Wang B, Weaver DJ, Liu B, Bui T, Arthos J, Serreze DV. Antigen-specific mediated suppression of beta cell autoimmunity by plasmid DNA vaccination. J Immunol. 2001 Feb 1;166(3):2122-32. doi: 10.4049/jimmunol.166.3.2122.
- Background: PubMed 12107747Jun HS, Chung YH, Han J, Kim A, Yoo SS, Sherwin RS, Yoon JW. Prevention of autoimmune diabetes by immunogene therapy using recombinant vaccinia virus expressing glutamic acid decarboxylase. Diabetologia. 2002 May;45(5):668-76. doi: 10.1007/s00125-002-0806-9. Epub 2002 Apr 4.
- Results publication: PubMed 21714999Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/tn08-gad-new-onset/?query=tn08
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Wherrett, M.D. principal investigator
University of Toronto, Hospital for Sick Children
Jay Skyler, M.D. study chair
University of Miami
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GAD-Alum, GAD-Alum and Aluminum hydroxide and Aluminum hydroxide in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit (time frame: Based on mixed meal tolerance test (MMTT) conducted at the one year visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529399, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.