Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus - NCT00453375-68131 (Clinical Trial 166747)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy166747.aspx
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| City: |
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Omaha |
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State:
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NE |
| Zip Code: |
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68131 |
| Conditions: |
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Diabetes - Hypoglycemia |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 ≥ 0.066 pmol/mL
Exclusion Criteria:
- Agree to intensive management of diabetes with a HgbA1c goal of < 7.0%
- 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 |
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| Study is available at: |
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Creighton Diabetes Center
Omaha, NE 68131
United States
Primary Contact:
Benjamin Bumgarner
Email: bjb@creighton.edu
Phone: 402-280-4324
Secondary Contact:
Kathryn A Woody
Email: kwoody@bayhilltx.com
Phone: 650-320-2838 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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