A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239187
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : July 21, 2008
Information provided by:
Transition Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: E1 and G1 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Response of Repeated Subcutaneous Doses of E1 in Combination With G1 in Patients With Type 2 Diabetes
Study Start Date : September 2005
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239187

United States, California
Profil Institute for Clinical Research Inc.
Chula Vista, California, United States, 91911
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765-2616
United States, Texas
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801
Sponsors and Collaborators
Transition Therapeutics
Study Director: Aleksandra Pastrak, M.D. Transition Therapeutics Identifier: NCT00239187     History of Changes
Other Study ID Numbers: INT-202
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2006

Keywords provided by Transition Therapeutics:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases