Status:
COMPLETED
ATG-GCSF in New Onset Type 1 Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
12-45 years
Phase:
PHASE2
Brief Summary
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (AT...
Detailed Description
The primary statistical hypothesis to be assessed in the study is whether the 2 hour area under the curve (change in baseline to 12 months) in residual beta cell function (C-peptide) will differ betwe...
Eligibility Criteria
Inclusion
- Must be \> 12 years \< 46
- 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
- Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (\< 3,000 leukocytes /µL), neutropenia (\<1,500 neutrophils/µL), lymphopenia (\<800 lymphocytes/µL), or thrombocytopenia (\<100,000 platelets/µL).
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02215200
Start Date
December 1 2014
End Date
August 1 2018
Last Update
March 2 2020
Active Locations (13)
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1
University of California - San Francisco
San Francisco, California, United States, 94158-2549
2
Stanford University
Stanford, California, United States, 94305
3
Barbara Davis Center
Aurora, Colorado, United States, 80045
4
Yale University
New Haven, Connecticut, United States, 06519