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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
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
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
7. No significant or active disease in any body system likely to increase
interfere with the subjectడrticipation/completion of study.
8. No investigational drug within last 3 months before signing informed
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
Go to www.clinicaltrials.gov the
identifier for this study is NCT01123083
Send e mail to
firstname.lastname@example.org with questions or comments about this web site. Call
the office for appointment changes, cancels, insurance updates.
Copyright ⰰ0 Orlando Diabetes and Endocrine Specialists, PA
July 26, 2010
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