A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to determine whether E1 and G1 are safe and effective in the
treatment of type 1 diabetes.
Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta
cells. These cells produce insulin, which regulates blood glucose. The mainstay of current
treatment for type 1 diabetes is dietary control and daily parenteral administration of
insulin.
Recent diabetes research has increasingly focused on pancreatic islet cell replacement,
either by islet cell transplantation or by endogenous regeneration of islet cells. During
fetal development, islet precursor cells proliferate and differentiate into mature beta cells
capable of producing insulin. This process is known as islet cell neogenesis. Islet cell
neogenesis normally ceases around birth, however, the adult pancreas still retains
significant potential for islet regeneration, as shown by tissue repair following pancreatic
injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis
and increase pancreatic insulin production in diabetic animal models. It is therefore
postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1
diabetic patients.