Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

NO_LONGER_AVAILABLE

Conditions studied: Diabetes Mellitus, Type 1

In brief

The purpose of this protocol is to provide continued acess to immunosuppressive medications to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.

Key facts

Study ID

NCT01309022

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

Last updated by the study team

2016-02-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participation in clinical trial ITN005CT (reference: ClinicalTrials.gov record NCT00014911) at Harvard University (Massachusetts General Hospital), Washington University, or University of Miami.
• Immunosuppressive regimen consisting of a single agent or some combination from among the following: tacrolimus, sirolimus, mycophenolate mofetil, and mycophenolic acid.
• Willingness of participants to use an approved method of contraception before, during, and 12 weeks after study participation.
• Peak C-peptide >0.1 pmol/mL during a mixed meal tolerance test (MMTT) within 12 months of the screening visit.

You may not qualify if…

• Inability to understand and sign the informed consent document for this study.
• Any medical condition which in the opinion of the investigator should preclude participation.
• Serum creatinine > 1.6 mg/dL
• Insulin requirement > 1.0 IU/kg/day
• Hemoglobin A1C (HbA1C) result > 12%
• Hypoglycemia unawareness defined as the absence of adequate autonomic symptoms at plasma glucose levels of < 54 mg/dL requiring treatment with glucagon, outside assistance, or treatment in an emergency room or hospital within a 12-month period

Where it is running

• University of Miami — Miami, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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