Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00453375. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 With Open Label Cross-Over in Subjects With Type I Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.
Study identification
- NCT ID
- NCT00453375
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2006 (Type not available)
- Primary completion
- May 2011 (Actual)
- Completion
- May 2011 (Actual)
- Last update posted
- Jun 28, 2011
2006 – 2011
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | Birmingham | Alabama | 35294 | — |
| Valley Research | Fresno | California | 93720 | — |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | — |
| Private Practice | Denver | Colorado | 80209 | — |
| MedStar Research Institute | Washington D.C. | District of Columbia | 20003 | — |
| University of Miami, Miller School of Medicine, Diabetes Research Institute | Miami | Florida | 33136 | — |
| Private Practice | Wellington | Florida | 33414 | — |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | — |
| Diabetes and Glandular Disease Center | San Antonio | Texas | 78229 | — |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | 98101-2795 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00453375, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 28, 2011 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00453375 live on ClinicalTrials.gov.