TrialNet Publications Committee Chair University of South Florida (NIH/NIDDK) U01DK106993Apr 1, 2022 - Jun 30, 2025 Role: TrialNet Publications Committee Chair Description: Dr. Gitelman will serve as Publications Committee Chair, partnering with the TrialNet Publications Office. |
ITN Study: Siplizumab T1D Study Benaroya Research Institute / NIH NIAID Subcontract FY20ITN372Jun 1, 2020 - Jan 31, 2026 Role: Principal Investigator Description: The protocol Development Chair will have an overall responsibility for the study development and protocol creation. The Protocol Development Chair will also interact with regulatory agencies, as needed, for the matters regarding this clinical trial. The protocol Chair will work under the guidance of the Immune Tolerance Network members. |
UCSF TrialNet NIH U01DK106993May 1, 2020 - Jun 30, 2025 Role: Principal Investigator Description: The goal of this study is to establish and maintain a Clinical Center of TrialNet at the University of California at San Francisco (UCSF), with the ultimate long-term objective to develop therapies to prevent type 1 diabetes. |
Diabetes Autoimmunity Withdrawn in New Onset and In Established Patients Tolerion, Inc. Private GrantNov 4, 2019 - Nov 4, 2024 Role: Principal Investigator Description: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of TOL-3021 in Patients with New Onset or Established type 1 Diabetes Mellitus. |
Rituximab Followed by Abatacept for Prevention or Reversal of Type 1 Diabetes (T1D) Helmsley Charitable Trust A134421Oct 1, 2019 - Sep 30, 2021 Role: Principal Investigator Description: To develop safe and effective means to delay or prevent progression to T1D among those with multiple antibodies and abnormal glucose tolerance. This funding is intended to support the purchase of Rituximab, in sufficient quantity to complete the trial. |
A Multicenter, Multinational Extension of Study PRV-031-001 Provention Bio, Inc. 136738AAug 20, 2019 - Mar 9, 2026 Role: Principal Investigator Description: The goal of this study is to evaluate the long-term safety of Teplizumab (PRV-031), a humanized, FcR non-binding, anti-CD3 monoclonal antibody, in children and adolescents with recent-onset Type 1 diabetes mellitus. |
Novel metabolic evaluation of new onset type 1 diabetes trials Indiana University 1R32DK119800Jul 1, 2019 - Apr 30, 2024 Role: Principal Investigator Description: The goal of the study is to assess beta cell glucose sensitivity in new onset trials in type 1 diabetes, including use of imatinib, as well as other trials conducted in TrialNet and the Immune Tolerance Network. |
19-27179, PROTECT Provention Bio, Inc PRV-031-001May 1, 2019 - Mar 9, 2026 Role: Principal Investigator Description: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D). |
A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D) IntrexonT1D Partners, LLC Private GrantFeb 23, 2019 - Feb 23, 2025 Description: The goal of this study is to evaluate a modified Lactococcus secreting IL-10 and pro-insulin without or with anti-CD3 monoclonal antibody in an early clinical trial in type 1 diabetes to assess safety and possible efficacy. |
SIMPONI to arrest beta cell loss in type 1 diabetes (the T1GER study) Janssen Research and Development Private GrantFeb 1, 2017 - Mar 16, 2025 Role: Principal Investigator Description: The goal of this proposal will be to evaluate the safety and efficacy of Simponi in a phase 2 trial in new onset type 1 diabetes. |
A phase 2 trial to assess safety and efficacy of polyclonal Treg therapy in new onset Type 1 Diabetes Caladrius Biosciences Private GrantApr 1, 2016 - Nov 8, 2021 Role: Principal Investigator Description: The goal of this multi-center study is to conduct a phase II study to assess safety and efficacy of autologous ex vivo expanded polyclonal regulatory T cells (Tregs) in new onset type 1 diabetes. |
ITN066AI (T1DES): Initial Participants Participated in T1DAL, Receiving Alefacept, and AbATE, Receiving Teplizumab Benaroya Research Institute / NIH NIAID Subcontract FY16ITN182Feb 1, 2016 - Jun 30, 2027 Role: Principal Investigator Description: The goal of this study is to conduct long term follow up of subjects in prior clinical research studies, and assess durability of effects on beta cell function, and any possible long term safety concerns. |
Diabetes Endocrinology Research Center NIH/NIDDK P30DK063720Apr 1, 2015 - Mar 31, 2022 Role: Co-Investigator, Program Director of Translation Description: The goal of the Center is to support a highly interactive team investigating type 1 and type 2 diabetes to advance the study and treatment of the disease. The Center encompasses a broad range of intellectual and research expertise from 21 departments and research units and 4 UCSF campuses focused on both basic and clinical research. I oversee the program in translational research. |
ITN058AI EXTEND - Preserving Beta-Cell Function with Tocilzumab in New Onset Type 1 Diabetes Benaroya Research Institute / NIH NIAID Subcontract FY15ITN104Sep 1, 2014 - Jan 31, 2022 Role: Principal Investigator Description: The goal of this study is to determine whether tocilizumab will slow the progression of the autoimmune destruction of ß cells and lead to the preservation of C-peptide secretion in T1DM. |
Safety and efficacy of Imatinib (Gleevec) for preserving Beta-cell function in new onset type 1 diabetes Juvenile Diabetes Research Foundation 17-2013-6Oct 1, 2013 - Mar 31, 2020 Role: Principal Investigator Description: The goal of this study will be to determine if Imatinib is a safe and effective means to preserve endogenous insulin secretion in subjects with new onset type 1diabetes. I will serve as the study PI on this phase 2 trial. |
K12 In Diabetes (KIDS) NIH K12DK094726Sep 16, 2011 - Jun 30, 2017 Role: Principal Investigator |
VGR-1/BMP-6 AND CHONDROGENESIS AND OSTEOGENESIS NIH K08AR001897Apr 1, 1993 - Mar 31, 1998 Role: Principal Investigator |
PEDIATRIC CLINICAL RESEARCH CENTER NIH M01RR001271Dec 1, 1981 - Mar 31, 2007 Role: Co-Investigator |
Training Program in Pediatric Endocrinology NIH/NIDDK T32DK007161Jul 1, 1976 - Jun 30, 2027 Role: Principal Investigator Description: Produce innovative scientific and clinical leaders in this field of Pediatric Endocrinology fellows, committed to academic careers by fostering scientific career development. |