Type 1 Diabetes Clinical Trial
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
NCT number | NCT00239148 |
Other study ID # | INT-201 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 2005 |
Est. completion date | December 2006 |
Verified date | October 2019 |
Source | OPKO Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pinnacle Research Group | Anniston | Alabama |
United States | Diabetes - Endocrinology Center of West New York | Buffalo | New York |
United States | Highgate Specialty Center | Durham | North Carolina |
United States | Diabetes and Glandular Disease Research Associates | San Antonio | Texas |
United States | Diablo Clinical Research | Walnut Creek | California |
Lead Sponsor | Collaborator |
---|---|
OPKO Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes | |||
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|
||
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |