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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayhill Therapeutics
• Treatments: Butylated Hydroxytoluene

Criteria

Inclusion Criteria

• Diagnosis of Type 1a Diabetes Mellitus based on ADA Criteria

• ≤5 years since T1D was diagnosed

• ≥ 18 years of age

• ≤ 40 years of age at the time of diagnosis of Type 1a diabetes

• Presence of antibodies to at least one of the following antigens:

insulin, GAD-65, or IA-2

• Detectable fasting C-peptide level

• C-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/mL

• Presence of antibodies to at least one of the following antigens: insulin, GAD-65, or IA-2. If insulin antibody positive only, determination must be within 2 weeks of insulin initiation

Exclusion Criteria:

• 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