Title: A Pilot Study to Determine the Safety
of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed
Subjects with Type 1 Diabetes Mellitus, PI: Luis Fernandez,
MD
Eligibility Criteria
Newly diagnosed autoimmune type 1 diabetes within 2-12 weeks
of diagnosis
Male and Female subjects 18-35 years of age
No prior organ transplant and no current use of prednisone (steroids)
No history of cancer (other than skin cancer)
No history of anemia (low red blood cell count)
No history of Hepatitis B or Hepatitis C
Study Summary
This research study is being done to look at whether it is safe
to use a new type of investigational medication called Campath-1H
to treat type 1 diabetes mellitus. Diabetes mellitus is a condition
that occurs when the body does not make enough insulin. One of
the problems that happens with diabetes mellitus is the body’s
immune system destroys cells that produce insulin (called beta
cells). One possible way of treating type 1 diabetes mellitus
is to try to stop the body from killing its own beta cells. We
think Campath-1H may be used to stop the body from destroying
further beta (insulin-producing) cells in subjects that have been
newly diagnosed with type 1 diabetes mellitus. In addition, we
also will try to find out if type 1 diabetic subjects who receive
Campath-1H will need to take less insulin each day to prevent
hyperglycemia (high blood sugar). If you decide to participate
in this research study, you will be randomly assigned by chance
into one of two groups. One group will receive Campath-1H, prednisone
(a steroid) and Benadryl (to prevent a reaction to the study medications),
and the usual, approved treatment for diabetes. The second group
will only receive the usual, approved treatment for diabetes.
If you agree to take part in this research study, you will have
a study screening visit to see if you can take part in this study.
Once enrolled in the study, you will come for study visits on
days 1, 2, 7, 14, and at Months 1, 2, 3, 6, 9, 12, 15, 18, 21
and 24 after starting the study. At each study visit you will
have blood tests performed and at several visits you will have
a physical examination to make sure that you are doing well. You
will be asked about any health problems you have noticed at each
visit. You will also have a procedure done to find out how many
cells that make insulin (beta cells) are in your body at the start
of your treatment and at 3, 6, 9, 12, 15, 18, 21 and 24 months
after the start of the study.
