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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO Health, Inc.; Transition Therapeutics

Criteria

Inclusion Criteria:

• Clinical diagnosis Type 1 diabetes requiring treatment with insulin for a minimum of 1 year

• On a stable insulin regimen for at least 60 days prior to screening

• Currently self monitoring blood glucose levels at least 3 times per day

• No episodes of severe hypoglycemia for 60 days prior to screening

• Body mass index within the range 19-30 kg/m2

• Patient cannot live alone during the treatment phase and up to 1 month in follow-up

Exclusion Criteria:

• Known of suspected history of significant liver, or other GI disease

• History of significant cardiovascular disease including stroke, peripheral vascular disease or any related symptoms

• History of peptic ulcer disease and/or GI bleeding/perforation

• History of cancer

• History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease

• History of treated peripheral or autonomic neuropathy

• Serum creatine superior or equal to 2.0 mg/dL

• History of hypoglycemia unawareness

• Non-healed diabetic ulcer