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Phase II trial of hOKT3g1(Ala-Ala), Teplizumab

for treatment of patients with recent onset Type 1 diabetes mellitus (Delay Study)


 

Principal Investigator: Peter Gottlieb MD, COMIRB # : 07-0927

The “Delay” Research Study is looking for people recently diagnosed with type 1 diabetes within the past 4-12 months. 

This research study will use the medication hOKT3g1(Ala-Ala), also called Teplizumab, to see if we can change the immune system to maintain the body’s ability to produce some insulin.

Why should you consider this study?

  • When you are first diagnosed with Type 1 Diabetes you still make some insulin
  • Over time, your body will lose the ability to make this insulin
  • This study will use a medication to try to keep your body making its own insulin
  • This medication has been shown to extend the honeymoon period in new onset subjects
  • While your body continues to make its own insulin, your diabetes will be easier to control
  • Continued production of some insulin can decrease the risk for long term complications of type 1 diabetes

Who can sign up for this study?

  • People recently diagnosed with Type 1 Diabetes within the past 4 – 12 months
  • 8 years old – 30 years old

What will happen in this study?

  • You will be assessed for general health and diabetes care
  • If you qualify, you will receive treatment with study medication, or fake medication, once per day for 14 consecutive days
  • You will be monitored for up to 2 additional years to look at your overall diabetes health

Who should I call with questions or to schedule an appointment?

Whitney Kastelic: 303-724-7502 or Whitney.Kastelic@ucdenver.edu
Lisa Meyers:      303-724-6893 or Lisa.Meyers@ucdenver.edu

http://clinicaltrials.gov/ct2/show/NCT00378508