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NCT00239148 · ClinicalTrials.gov registry record · Phase 1
A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
A Phase 1 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00239148 is a Phase 1 study that has completed, run by OPKO Health. The registered enrollment target is 20 participants.
The verdict
NCT00239148, a Phase 1 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG E1 and G1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-06 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00239148
The ClinicalTrials.gov registry entry for NCT00239148 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which E1 and G1 is the first listed.
NCT00239148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00239148 about?
NCT00239148 is a clinical study titled "A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1". 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 curr...
What is the current status of trial NCT00239148?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-06. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00239148?
The interventions under investigation include: E1 and G1 (DRUG).
Who is sponsoring clinical trial NCT00239148?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
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