A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      In this study, 30 type 2 diabetic patients requiring oral hypoglycemic therapy with Metformin
      and/or Thiazolidinedione will be randomized. Twenty (20) patients will be randomized to
      receive active study medication and 10 patients will be randomized to receive vehicle
      control. After undergoing screening procedures, potential patients will enter a 14 day
      baseline phase where baseline data will be collected. Pending successful completion of the
      baseline phase, patient will enter a 28-day treatment phase where they will be randomized to
      receive either once daily subcutaneous injections of E1 plus G1, as separate injections or
      once daily subcutaneous injections of vehicle control (as 2 separate injections). Patients
      will receive once daily doses in the morning after breakfast for a period of 28 days. Upon
      completion of treatment, all patients will continue in the follow-up phase for an additional
      6 months and will return to the clinic for monthly visits. Throughout the study, patients
      will remain on their current oral hypoglycemic therapy with Metformin and/or
      Thiazolidinedione and will maintain a diary record of blood glucose levels.

      The body's ability to control glucose will be assessed by oral glucose tolerance test (OGTT).
      After an overnight fast, patients will be asked to drink a solution containing a known amount
      of glucose. Blood samples for glucose and insulin measurements will be obtained before the
      patients drink the glucose solution, and again 30 minutes, 60 minutes and 2 hours after the
      glucose is consumed. This test will be performed at frequent intervals during the study.
    

Intervention name(s): E1 and G1
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes