Status:
COMPLETED
Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
Lead Sponsor:
Bayhill Therapeutics
Conditions:
Diabetes
Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (...
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-pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00453375
Start Date
October 1 2006
End Date
May 1 2011
Last Update
June 28 2011
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35294
2
Valley Research
Fresno, California, United States, 93720
3
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
4
Private Practice
Denver, Colorado, United States, 80209