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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes, Hypoglycemia

In brief

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.

Key facts

Study ID

NCT00453375

Run by

Bayhill Therapeutics

People needed

80

Starts

2006-10-01

Expected to finish

2011-05-01

Last updated by the study team

2011-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• 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

Full record on ClinicalTrials.gov

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