Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
- Registration Number
- NCT00453375
- Lead Sponsor
- Bayhill Therapeutics
- Brief Summary
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.
- Detailed Description
Type 1 diabetes results from an attack by the body's own immune system on the insulin producing cells in the pancreas. Around 80% of diagnosed patients have detectable antibodies to islet cell self-proteins including, insulin IA-2 and glutamic acid decarboxylase. The drug, BHT-3021 is being studied because an agent that stops autoimmune damage could offer patients benefit.
Study Description: A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes Mellitus that will enroll up to 72 subjects in this trial. Subjects will be randomized to BHT-3021 or BHT-placebo in a 2:1 ratio.
The duration of the study is approximately 25 to 37 months depending on treatment assignment: 4 week Screening Period; 12 month Blinded Treatment and Evaluation Period; 12 month Cross-over Treatment and Evaluation Period (BHT-placebo subjects only); 12 month Long Term Follow-Up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
- BMI > 30 kg/m2
- Unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
- Current use of inhalable insulin
- Previous immunotherapy for T1D
- Administration of an experimental agent for T1D at any time or use of an experimental device for T1D within 30 days prior to screening, unless approved by the medical monitor
- History of any organ transplant, including islet cell transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 BHT-3021 BHT-3021 2 BHT-Placebo BHT-Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (17)
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
🇺🇸Wellington, Florida, United States
MedStar Research Institute
🇺🇸Washington, District of Columbia, United States
University of Miami, Miller School of Medicine, Diabetes Research Institute
🇺🇸Miami, 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
Peninsula Clinical Research Centre
🇦🇺Kippa Ring, Queensland, Australia
Scroll for more (7 remaining)University of Alabama at Birmingham School of Medicine🇺🇸Birmingham, Alabama, United States