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: 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 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.

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

Details

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

Criteria

Inclusion Criteria:

• Informed consent obtained from participants

• Clinical diagnosis Type 2 diabetes requiring treatment with Metformin and/or TZD and who are otherwise healthy

• On a stable Metformin and/or TZD regimen for at least 60 days prior to screening

• Maximum stimulated c-peptide level > 0.6 nmol/L (1.8 ng/mL)

• Currently self monitoring blood glucose levels (i.e. daily)

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

• Body mass index within the range 25-40 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

• Non-healed diabetic ulcer

• History of hypoglycemic unawareness