A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT - NCT00751842-48126 (Clinical Trial 360801)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy360801.aspx
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| City: |
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Dearborn |
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State:
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MI |
| Zip Code: |
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48126 |
| Conditions: |
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Type 1 Diabetes Mellitus |
| Purpose: |
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The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is
effective in preserving the body's own insulin producing capacity in patients recently
diagnosed with type 1 diabetes.
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| Study summary: |
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| Criteria: |
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Main Inclusion Criteria:
- Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at
time of screening
- Fasting C-peptide level at time of screening above 0.1 nmol/L
- Elevated GAD65 antibodies (GADA) at time of screening
- Male and female patients between 10 and 20 years of age
Main Exclusion Criteria:
- Treatment with immunosuppressants or any anti-diabetic medications other than insulin
- A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy,
head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse
etc)
- Treatment with any vaccine within 1 month prior to planned first Diamyd dose or
planned treatment with vaccine up to 2 months after the last injection with Diamyd,
excluding the influenza vaccine
- Participation in other clinical trials with a new chemical entity within the previous
3 months
- Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
- Presence of associated serious disease or condition which in the opinion of the
investigator makes the patient non-eligible for the study |
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| Study is available at: |
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Alzohaili Medical Consultants
Dearborn, MI 48126
United States
Primary Contact:
Email: alzohailiresearch@hotmail.com
Phone: 313-581-8903
Secondary Contact:
Donna Patch
Email: dpatch@tklresearch.com
Phone: 201-587-0500 |
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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 16, 2010 |
Modifications to
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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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