Reversing Type 1 Diabetes After it is Established

• Status: Completed
• Trial end date: 2019-07-16
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: Genzyme, a Sanofi Company; The Leona M. and Harry B. Helmsley Charitable Trust
• Treatments: 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