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NCT01030861 · ClinicalTrials.gov registry record · Phase 2
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
A Phase 2 study of Impaired Glucose Tolerance and High-risk, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 19
- Study locations
NCT01030861: Completed Phase 2 study of Impaired Glucose Tolerance and High-risk, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01030861 is a Phase 2 study of Impaired Glucose Tolerance and High-risk that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 76 participants, below the 84-participant average among 13 other Impaired Glucose Tolerance trials with a reported enrollment target (10% lower). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01030861, a Phase 2 study of Impaired Glucose Tolerance and High-risk, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 19
- Study locations
Study Summary
The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
Primary Outcome
Rate at which criteria are met for diabetes onset as defined by the American Diabetes Association (ADA) based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation.
Conditions Studied
Interventions
- DRUG Placebo infusion
- DRUG Teplizumab
Study Locations (19)
California
- University of California in San Francisco - San Francisco
- University of California-San Francisco - San Francisco
- Stanford University - Stanford
Florida
- University of Florida - Gainesville
- University of Miami - Miami
- University of South Florida - Tampa
Texas
- University of Texas - Dallas
- Baylor College of Medicine - Houston
Colorado
- Barbara Davis Center for Childhood Diabetes/ University of Colorado - Denver
Connecticut
- Yale University School of Medicine - New Haven
Indiana
- Indiana University - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
Missouri
- The Children's Mercy Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2010-08 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
What the finished NCT01030861 record still lists
NCT01030861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 84-participant average among 13 other Impaired Glucose Tolerance trials with a reported enrollment target (10% lower).
The record links to 4 conditions, with Impaired Glucose Tolerance appearing as the primary indexed condition, and to 2 interventions - of which Placebo infusion is the first listed.
NCT01030861 lists 19 locations in 14 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT01030861 about?
NCT01030861 is a clinical study titled "Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"". The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy ...
What is the current status of trial NCT01030861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2010-08. Estimated completion is 2019-06.
What conditions does trial NCT01030861 study?
This clinical trial studies the following conditions: Impaired Glucose Tolerance, High-risk, Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes.
What interventions are being tested in trial NCT01030861?
The interventions under investigation include: Placebo infusion (DRUG), Teplizumab (DRUG).
Who is sponsoring clinical trial NCT01030861?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01030861 being conducted?
This trial has 19 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Impaired Glucose Tolerance
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 NCT01030861's enrollment target sits among peer trials
76 5th of 13 higher than 9 of 13 other Impaired Glucose Tolerance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Impaired Glucose Tolerance 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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