Overview
Reversing Type 1 Diabetes After it is Established
Status:
Completed
Completed
Trial end date:
2019-07-16
2019-07-16
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary purpose of this study is to determine if giving the combination therapy consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1 Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of FloridaCollaborators:
Genzyme, a Sanofi Company
The Leona M. and Harry B. Helmsley Charitable TrustTreatments:
Thymoglobulin
Criteria
Inclusion Criteria:- Must be > 12 years < 45
- Must have a diagnosis of T1D of greater than 4 months duration, with an upper limit of
2 years, Now only recruiting for those diagnosed greater than 1 year but less than 2
years.
- Must have at least one diabetes-related autoantibody present (e.g., islet cell
autoantigen (ICA), GAD, ZnT8, or islet antigen 2 (IA2) autoantibodies)
- Must have stimulated C-peptide levels ≥ 0.1 pmol/ml (0.3ng/mL) when measured during a
mixed meal tolerance test (MMTT), conducted at least 4 months from diagnosis of
diabetes, and within 8 weeks of randomization
- Must be EBV PCR negative within two weeks of randomization if EBV seronegative at
screening
- Be at least 6 weeks from last live immunization
- Be willing to forgo live vaccines for 3 months following last dose of study drug
- Be willing to comply with intensive diabetes management
- Normal screening values for complete blood count (CBC), renal function and
electrolytes (CMP).
Exclusion Criteria:
- Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (<
3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800
lymphocytes/μL), or thrombocytopenia (<125,000 platelets/μL).
- Have a chronic infection at time of randomization
- Have a positive PPD
- Be currently pregnant or lactating, or anticipate getting pregnant within the next two
years
- Require use of other immunosuppressive agents
- Have serologic evidence of current or past HIV, Tuberculosis, Hepatitis B or Hepatitis
C infection
- Have any complicating medical issues or abnormal clinical laboratory results that
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 (e.g., lymphopenia, leukopenia, or
thrombocytopenia)
- Have a history of malignancies
- Evidence of liver dysfunction with angiotensin sensitivity test (AST) or 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 use of non-insulin pharmaceuticals that affect glycemic control
- Active participation in another T1D treatment study in the previous 30 days
- Known allergy to G-CSF 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