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Clinical trialNCT00453375CompletedPhase 1Interventional

Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus

SponsorBayhill TherapeuticsEnrollment80DiabetesHypoglycemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Peninsula Clinical Research Centre

    Kippa-Ring, Queensland, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, Australia

  • Eastern Clinical Research Unit

    Ringwood East, Victoria, Australia

  • Fremantle Hospital

    Fremantle, Western Australia, Australia

New Zealand
  • Middlemore Hospital

    Otahuhu, Auckland, New Zealand

  • Christchurch Hospital

    Christchurch, Canterbury, New Zealand

  • Waikato Regional Diabetes Service

    Hamilton, Waikato Region, New Zealand

  • the Diabetes Centre

    Newtown, Wellington Region, New Zealand

United States
  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama, United States

  • Valley Research

    Fresno, California, United States

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, United States

  • Private Practice

    Denver, Colorado, United States

  • Medstar Research Institute

    Washington D.C., District of Columbia, United States

  • University of Miami, Miller School of Medicine, Diabetes Research Institute

    Miami, Florida, United States

  • Private Practice

    Wellington, Florida, United States

  • Creighton Diabetes Center

    Omaha, Nebraska, United States

  • Diabetes and Glandular Disease Center

    San Antonio, Texas, United States

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BHT-3021BHT-Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2006
Primary completion
31 May 2011
Completion
31 May 2011
Last update posted
28 Jun 2011
Registered enrollment
80
Registry id
NCT00453375

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.