A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Status:
Completed
Trial end date:
2007-01-01
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 2 diabetes.
Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin
resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia
results from a failure of pancreatic beta cells insulin secretory capacity to adequately
compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is
achieved by dietary control, or a combination of diet and oral hypoglycemic agents or
insulin. As the disease progress, many type 2 diabetic patients eventually require insulin as
primary therapy to achieve glycemic control.
Recent diabetic 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 insulin production in diabetic animal models. In type 2 diabetic patients,
treatment with E1 and G1 may result in islet cell regeneration. This therapeutic approach may
improve beta cell function, restore the loss of insulin secretory capacity and also benefit
patients on oral hypoglycemic agents by delaying insulin use.