Islet Transplantation in Type 1 Diabetes

NCT00434811 Phase 3 COMPLETED

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	COMPLETED
Enrolment	48
Start date	2006-10
Completion	2014-05

Conditions

• Type 1 Diabetes Mellitus

Interventions

• Allogeneic Pancreatic Islet Cells
• Antithymocyte Globulin
• Sirolimus
• Tacrolimus
• Etanercept
• Islet Transplantation
• Basiliximab

Primary outcomes

• Proportion of participants with a HbA1c less than 7.0% AND free of severe hypoglycemic events — From Day 28 to Day 365 (inclusive) following the first islet transplant, with the day of transplant designated Day 0
  The proportion of participants with HbA1c ≤7.0% AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive, following the first islet transplant, with the day of transplant designated Day 0.

Countries

United States, Canada