A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1

October 17, 2019 updated by: OPKO Health, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • New York
      • Buffalo, New York, United States, 14209
        • Diabetes - Endocrinology Center of West New York
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Highgate Specialty Center
    • Texas
      • San Antonio, Texas, United States, 78229-4801
        • Diabetes and Glandular Disease Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (ESTIMATE)

October 14, 2005

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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