NCT00529399: TN08

Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects

Completed Phase 2 Results posted Last updated 27 April 2020

What this trial tests

Phase 2 trial testing GAD-Alum in Type 1 Diabetes Mellitus in 145 participants. Completed in 1 May 2012.

Timeline

1 February 2009

Primary endpoint
1 May 2012

1 May 2012

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	145
Start date	1 February 2009
Primary completion	1 May 2012
Estimated completion	1 May 2012
Sites	15 locations across United States, Canada

Drugs / interventions tested

• GAD-Alum — full drug profile →
• GAD-Alum and Aluminum hydroxide — full drug profile →
• Aluminum hydroxide — full drug profile →

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

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

Who can join

Adults 3 to 45, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial.
   Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, et al · · 2011 · cited 280× · PMID 21714999 · DOI 10.1016/s0140-6736(11)60895-7
2. Therapeutic induction of antigen-specific immune tolerance.
   Kenison JE, Stevens NA, Quintana FJ. · · 2024 · cited 94× · PMID 38086932 · DOI 10.1038/s41577-023-00970-x
3. Role of orally induced regulatory T cells in immunotherapy and tolerance.
   Bertolini TB, Biswas M, Terhorst C, Daniell H, et al · · 2021 · cited 61× · PMID 33248367 · DOI 10.1016/j.cellimm.2020.104251
4. Autoreactive T effector memory differentiation mirrors β cell function in type 1 diabetes.
   Yeo L, Woodwyk A, Sood S, Lorenc A, et al · · 2018 · cited 54× · PMID 29851415 · DOI 10.1172/jci120555
5. Efficacy of GAD-alum immunotherapy associated with HLA-DR3-DQ2 in recently diagnosed type 1 diabetes.
   Hannelius U, Beam CA, Ludvigsson J. · · 2020 · cited 52× · PMID 32754804 · DOI 10.1007/s00125-020-05227-z
6. New and future immunomodulatory therapy in type 1 diabetes.
   Tooley JE, Waldron-Lynch F, Herold KC. · · 2012 · cited 31× · PMID 22342807 · DOI 10.1016/j.molmed.2012.01.001
7. 2011 Update: antigen-specific therapy in type 1 diabetes.
   Michels AW, von Herrath M. · · 2011 · cited 28× · PMID 21844706 · DOI 10.1097/med.0b013e32834803ae
8. Immunosuppression in islet transplantation.
   Van Belle T, von Herrath M. · · 2008 · cited 25× · PMID 18431511 · DOI 10.1172/jci35639