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

Detailed description: 
      In this study, 20 type 1 diabetic patients requiring insulin therapy will be randomized.
      Fifteen (15) patients will be randomized to receive active study medication and 5 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 insulin regimen and will maintain
      a diary record of insulin intake and blood glucose levels.

      Pancreatic beta cell function or insulin secretion is best measured by determination of
      c-peptide (which is co-secreted with insulin in a 1:1 ratio). An arginine stimulated
      c-peptide test will therefore be performed at frequent intervals during the study. Patients
      will be injected with a solution containing arginine, a normal constituent of food that
      increases insulin release from beta cells into the blood. After the injection seven blood
      samples for c-peptide tests will be collected over 10 minutes.
    

Intervention name(s): E1 and G1
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 1 diabetes