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To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.
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Inclusion criteria
Patients must meet all of the following criteria to be eligible to participate in this study:
Exclusion criteria
Potential participants must not meet any of the following exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Central trial contact
Rodolfo Alejandro, M.D.; David A Baidal, M.D.
Data sourced from clinicaltrials.gov
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