(VERY EARLY, SMALL SAMPLE)
The treatment has been very safe and well tolerated by all the study subjects. Of the 12 patients in the Trial, seven had been diagnosed with Type 1 diabetes within one year from initial screening for the Trial. Data for these recently diagnosed patients are considered to be the most significant and relevant in measurement of the endpoints of the Trial. One endpoint of the Trial was to measure C-peptide levels of each patient following AAT therapy. Six months following the initial screening four of the seven patients showed increased C-peptide levels, whereas most Type 1 diabetics progressively lose their ability to produce endogenous insulin, and, therefore, demonstrate progressively decreasing levels of C-peptide. Another endpoint of the Trial was to measure insulin requirements during and following the AAT treatment. Three of the seven patients displayed decreased dependence on insulin during the 3-6 month period following the start of their eight week AAT therapy.