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Clinical Trial Details

Trial ID: L6121
Source ID: NCT00453375
Associated Drug: Bht-3021
Title: Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Hypoglycemia
Interventions: DRUG: BHT-3021|DRUG: BHT-Placebo
Outcome Measures: Primary: The primary endpoint in this study is safety.Safety parameters include: stimulated C-peptide response levels, opthalmologic examination, laboratory assessments, 24-hr urine protein, allergic reactions and adverse events including hypoglycemia. | Secondary: The secondary endpoints are pharmacodynamic parameters. Parameters include plasmid levels and insulin mRNA levels in blood and urine, Stimulated C-peptide response and Immunological response.
Sponsor/Collaborators: Sponsor: Bayhill Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-10
Completion Date: 2011-05
Results First Posted:
Last Update Posted: 2011-06-28
Locations: University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, 35294, United States|Valley Research, Fresno, California, 93720, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|Private Practice, Denver, Colorado, 80209, United States|MedStar Research Institute, Washington, District of Columbia, 20003, United States|University of Miami, Miller School of Medicine, Diabetes Research Institute, Miami, Florida, 33136, United States|Private Practice, Wellington, Florida, 33414, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|Diabetes and Glandular Disease Center, San Antonio, Texas, 78229, United States|Benaroya Research Institute at Virginia Mason, Seattle, Washington, 98101-2795, United States|Peninsula Clinical Research Centre, Kippa Ring, Queensland, 4021, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Eastern Clinical Research Unit, Ringwood East, Victoria, 3050, Australia|Fremantle Hospital, Fremantle, Western Australia, 6160, Australia|Middlemore Hospital, Otahuhu, Auckland, Private Bag 93311, New Zealand|Christchurch Hospital, Christchurch, Canterbury, Private Bag 4710, New Zealand|Waikato Regional Diabetes Service, Hamilton, Waikato, Private bag 3200, New Zealand|The Diabetes Centre, Newtown, Wellington, Private Bag 7902, New Zealand
URL: https://clinicaltrials.gov/show/NCT00453375

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress