Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
1. To reverse hyperglycemia and insulin dependency by islet cell transplantation, in
patients with Type 1 Diabetes Mellitus who have a stable kidney allograft;
2. To eliminate the incidence of hypoglycemic coma and unawareness by islet cell
transplantation;
3. To assess long-term function of successful islet cell transplants;
4. To determine whether the natural history of the microvascular, macrovascular and
neuropathic complications of Diabetes Mellitus are altered following successful
transplantation of islet cells.
5. To assess the effect of exenatide to improve islet graft function and survival in
subjects that demonstrate partial graft loss and have returned to using exogenous
insulin.
6. To assess the ability of exenatide to improve islet survival at time of islet
transplantation
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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