Reversing Type 1 Diabetes After it is Established

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT01106157

Run by

University of Florida

People needed

25

Starts

2010-04-01

Expected to finish

2019-07-16

Last updated by the study team

2019-08-05

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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