A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
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
1 other identifier
interventional
20
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2005
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 18, 2019
October 1, 2019
October 12, 2005
October 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes
Secondary Outcomes (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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Diabetes - Endocrinology Center of West New York
Buffalo, New York, 14209, United States
Highgate Specialty Center
Durham, North Carolina, 27713, United States
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229-4801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aleksandra Pastrak, M.D.
OPKO Health, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 14, 2005
Study Start
June 1, 2005
Study Completion
December 1, 2006
Last Updated
October 18, 2019
Record last verified: 2019-10