Julie A. Bauer, MD       Kimberley A. Webster-Bourne, MD, FACE

Know your Goal's  - A1C <7.0%,    Blood Pressure  <120/80,   Cholesterol <200.  Iif you are not meeting these goals -   Talk with your Dr.                      Clinical Trials

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We currently have 2 ongoing clinical trials.  Both clinical trials are for the newly diagnosed patient with Type 1 Diabetes.  Clinical trials in the USA are regulated by the FDA.  Patient safety is the #1 priority.  

The first clinical trial is called Defend2.  Below is the Key Eligibility Criteria.  Refer to the protocol for a complete list and description.

1. Male or female, 12 to 45 yrs old, inclusive, at the time of anticipated first dose.  Ages 12 to 17: > or = Tanner Stage 2 and > or = 31 kg. Adults: BMI < 32; Adolescents: < 95th percentile per US CDC criteria.
2. Diabetes mellitus (according to ADA/WHO criteria c/w autoimmune type 1a).
3. New onset diabetes: ≤ 90 d between initial diagnosis and 1st dose of study drug.
4. At least one T1DM autoantibody positive.
5. Stimulated C-peptide over 0.20 nmol/L during screening.
6. Not: pregnant; breastfeeding; planning pregnancy for 60 d after study drug admin.
7. No significant or active disease in any body system likely to increase risk or
interfere with the subjectà°Ħrticipation/completion of study.
8. No investigational drug within last 3 months before signing informed consent.
9. Not expected to require vaccine within last 30 d before first dose of study drug; not expected to require vaccine during dosing or for 14 d after last dose of study drug.
10. Screening laboratory results within protocol-specified ranges.

Please call our research department to speak with Albertha the study nurse to schedule time to discuss this clinical trial in more detail.  Her direct line is 407-237-0903.

Take a look at the official website for a complete description and more information. 


Go to www.clinicaltrials.gov the identifier for this study is NCT01123083


Send e mail to info@bestendo.com with questions or comments about this web site.  Call the office for appointment changes, cancels, insurance updates.
Copyright â°°0 Orlando Diabetes and Endocrine Specialists, PA
Last modified: July 26, 2010
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