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NCT02293837 · ClinicalTrials.gov registry record · Phase 2
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes Mellitus and T1D, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
- 19
- Study locations
NCT02293837: Completed Phase 2 study of Type 1 Diabetes Mellitus and T1D, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02293837 is a Phase 2 study of Type 1 Diabetes Mellitus and T1D that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 136 participants, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (20% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02293837, a Phase 2 study of Type 1 Diabetes Mellitus and T1D, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
- 19
- Study locations
Study Summary
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control. Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Primary Outcome
C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes post-meal. C-peptide mAUC was calculated using the trapezoidal rule over the 2-hour time peri
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Standard of Care
- DRUG Tocilizumab (TCZ)
Study Locations (19)
Florida
- University of Florida - Gainesville
- University of Miami: Diabetes Research Institute - Miami
- University of South Florida: Diabetes Center - Tampa
California
- University of California San Francisco - San Francisco
- Stanford University - Stanford
Connecticut
- Yale University School of Medicine: Diabetes Endocrinology Research Center - New Haven
Indiana
- Indiana University Health - Riley Hospital for Children - Indianapolis
Iowa
- University of Iowa - Iowa City
Massachusetts
- Harvard University, Joslin Diabetes Center - Boston
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Children's Mercy Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2015-03-12 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 2 |
What the finished NCT02293837 record still lists
NCT02293837 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (20% lower).
The record links to 4 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02293837 lists 19 locations in 16 states (Florida, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02293837 about?
NCT02293837 is a clinical study titled "Tocilizumab (TCZ) in New-onset Type 1 Diabetes". Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control. Researchers be...
What is the current status of trial NCT02293837?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2015-03-12. Estimated completion is 2020-08-31.
What conditions does trial NCT02293837 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, T1D, T1DM, New-onset Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT02293837?
The interventions under investigation include: Placebo (DRUG), Standard of Care (OTHER), Tocilizumab (TCZ) (DRUG).
Who is sponsoring clinical trial NCT02293837?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02293837 being conducted?
This trial has 19 study locations across California, Connecticut, Florida, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02293837's enrollment target sits among peer trials
136 23rd of 112 higher than 90 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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