Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2014-12-31
2018-08-31
Brief Summary
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The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.
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Detailed Description
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The study will also examine the effect of the proposed treatments on surrogate markers for immunologic and metabolic outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Anti-Thymocyte Globulin (ATG) and Placebo
Anti-Thymocyte Globulin (ATG)/Placebo: Anti-Thymocyte Globulin (ATG) will be administered at a dose of 2.5mg/kg as two divided IV infusions of 0.5mg/kg and 2mg/kg. First dose (0.5mg/kg) will be infused over a minimum of 12 hours, and the second dose (2mg/kg) over a minimum of 8 hours. The second dose should be given no less than 12 and no more than 24 hours after the previous dose.
Placebo(for GCSF) treatment will begin 6 hours after completion of the ATG. Placebo will be given subcutaneously every 2 weeks for a total of 6 doses
Anti-Thymocyte Globulin (ATG)
Thymoglobulin
Placebo (for GCSF)
Placebo prepared to mimic 6mg subcutaneous injection of GCSF
ATG plus Granulocyte colony stimulating factor (GCSF)
Granulocyte colony stimulating factor (GCSF) is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg GCSF (based on protein weight), in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), sorbitol (30.0 mg), polysorbate 20 (0.02 mg), and sodium (0.02 mg) in water for injection, U.S. Pharmacopeial Convention (USP). The standard 6mg dose will be given with the exception of subjects who weigh less than 45 kg.
GCSF treatment will begin 6 hours after completion of the ATG / Placebo. GCSF will be given subcutaneously every 2 weeks for a total of 6 doses
Anti-Thymocyte Globulin (ATG)
Thymoglobulin
Granulocyte colony stimulating factor (GCSF)
Granulocyte colony stimulating factor (GCSF)
Placebo
Placebo for ATG will be administered by IV infusion in 2 doses. Placebo for GCSF will be administered subcutaneously every 2 weeks for a total of 6 doses
Placebo (for ATG)
Normal saline administered by IV infusion to mimic ATG
Placebo (for GCSF)
Placebo prepared to mimic 6mg subcutaneous injection of GCSF
Interventions
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Anti-Thymocyte Globulin (ATG)
Thymoglobulin
Granulocyte colony stimulating factor (GCSF)
Granulocyte colony stimulating factor (GCSF)
Placebo (for ATG)
Normal saline administered by IV infusion to mimic ATG
Placebo (for GCSF)
Placebo prepared to mimic 6mg subcutaneous injection of GCSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a diagnosis of T1D for less than 100 days at randomization
* Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age
* Positive for at least one islet cell autoantibody; glutamic acid decarboxylase 65 (GAD65A), Insulin micro IAA (mIAA), if obtained within 10 days of the onset of insulin therapy, islet antigen 2 (IA-2A), Islet Cell Antigen (ICA), or zinc transporter 8 (ZnT8A)
* Must have stimulated C-peptide levels = 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
* Must be Epstein-Barr virus (EBV PCR) negative within two weeks of randomization if EBV seronegative at screening
* Be at least 6 weeks from last live immunization
* Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available
* Be willing to forgo vaccines during the treatment period and for 3 months following last dose of study drug
* Be willing to comply with intensive diabetes management
Exclusion Criteria
* Have active signs or symptoms of acute infection at the time of randomization
* Have evidence of prior or current tuberculosis infection as assessed by purified protein derivative (PPD), interferon gamma release assay (IGRA) or by history
* Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period
* Require use of other immunosuppressive agents including chronic use of systemic steroids
* Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
* Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities
* Have a history of malignancies other than skin
* Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
* Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
* Vaccination with a live virus within the last 6 weeks
* Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening
* Active participation in another T1D treatment study in the previous 30 days
* Prior treatment with abatacept or anti-cd3
* Known allergy to GCSF or ATG
* Prior treatment with ATG or known allergy to rabbit derived products
* Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
12 Years
45 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Center for Research Resources (NCRR)
NIH
Juvenile Diabetes Research Foundation
OTHER
American Diabetes Association
OTHER
Sanofi
INDUSTRY
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Amgen
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Michael J Haller, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of California - San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida Diabetes Center
Tampa, Florida, United States
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University-Naomi Berrie Diabetes Center
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, United States
Benaroya Research Institute
Seattle, Washington, United States
Countries
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References
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Jacobsen LM, Diggins K, Blanchfield L, McNichols J, Perry DJ, Brant J, Dong X, Bacher R, Gersuk VH, Schatz DA, Atkinson MA, Mathews CE, Haller MJ, Long SA, Linsley PS, Brusko TM. Responders to low-dose ATG induce CD4+ T cell exhaustion in type 1 diabetes. JCI Insight. 2023 Aug 22;8(16):e161812. doi: 10.1172/jci.insight.161812.
Haller MJ, Long SA, Blanchfield JL, Schatz DA, Skyler JS, Krischer JP, Bundy BN, Geyer SM, Warnock MV, Miller JL, Atkinson MA, Becker DJ, Baidal DA, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Herold KC, Marks JB, Moran A, Rodriguez H, Russell WE, Wilson DM, Greenbaum CJ; Type 1 Diabetes TrialNet ATG-GCSF Study Group. Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data. Diabetes. 2019 Jun;68(6):1267-1276. doi: 10.2337/db19-0057. Epub 2019 Apr 9.
Haller MJ, Schatz DA, Skyler JS, Krischer JP, Bundy BN, Miller JL, Atkinson MA, Becker DJ, Baidal D, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Herold KC, Marks JB, Moran A, Rodriguez H, Russell W, Wilson DM, Greenbaum CJ; Type 1 Diabetes TrialNet ATG-GCSF Study Group. Low-Dose Anti-Thymocyte Globulin (ATG) Preserves beta-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes. Diabetes Care. 2018 Sep;41(9):1917-1925. doi: 10.2337/dc18-0494. Epub 2018 Jul 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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Type 1 Diabetes TrialNet
Other Identifiers
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Type 1 Diabetes TrialNet
Identifier Type: OTHER
Identifier Source: secondary_id
TN19
Identifier Type: OTHER
Identifier Source: secondary_id
ATG-GCSF (IND)
Identifier Type: -
Identifier Source: org_study_id
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