Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
NCT01030861 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01030861
The ClinicalTrials.gov registry entry for NCT01030861 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01030861 reports 19 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes, High Risk. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01030861?
The interventions under investigation include: Placebo infusion (DRUG), Teplizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01030861?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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