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A Study in Type 1 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: NCT00239148
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : October 18, 2019
Information provided by:
OPKO Health, Inc.

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Effects of Repeated Subcutaneous Doses of E1 in Combination With G1 in Type 1 Diabetes
Study Start Date : June 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00239148

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United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, New York
Diabetes - Endocrinology Center of West New York
Buffalo, New York, United States, 14209
United States, North Carolina
Highgate Specialty Center
Durham, North Carolina, United States, 27713
United States, Texas
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801
Sponsors and Collaborators
OPKO Health, Inc.
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Study Director: Aleksandra Pastrak, M.D. OPKO Health, Inc.
Layout table for additonal information Identifier: NCT00239148    
Other Study ID Numbers: INT-201
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Keywords provided by OPKO Health, Inc.:
Type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases