A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Response of Repeated Subcutaneous Doses of E1 in Combination With G1 in Patients With Type 2 Diabetes
1 other identifier
interventional
30
1 country
3
Brief Summary
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 2 diabetes. Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia results from a failure of pancreatic beta cells insulin secretory capacity to adequately compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is achieved by dietary control, or a combination of diet and oral hypoglycemic agents or insulin. As the disease progress, many type 2 diabetic patients eventually require insulin as primary therapy to achieve glycemic control. Recent diabetic 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 insulin production in diabetic animal models. In type 2 diabetic patients, treatment with E1 and G1 may result in islet cell regeneration. This therapeutic approach may improve beta cell function, restore the loss of insulin secretory capacity and also benefit patients on oral hypoglycemic agents by delaying insulin use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Sep 2005
Typical duration for phase_1 type-2-diabetes
3 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
September 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
January 1, 2007
CompletedOctober 18, 2019
October 1, 2019
October 12, 2005
October 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
Secondary Outcomes (1)
To evaluate the pharmacokinetics (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent obtained from participants
- Clinical diagnosis Type 2 diabetes requiring treatment with Metformin and/or TZD and who are otherwise healthy
- On a stable Metformin and/or TZD regimen for at least 60 days prior to screening
- Maximum stimulated c-peptide level \> 0.6 nmol/L (1.8 ng/mL)
- Currently self monitoring blood glucose levels (i.e. daily)
- No episodes of severe hypoglycemia for 60 days prior to screening
- Body mass index within the range 25-40 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
- Non-healed diabetic ulcer
- History of hypoglycemic unawareness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Profil Institute for Clinical Research Inc.
Chula Vista, California, 91911, United States
Clinical Research of West Florida
Clearwater, Florida, 33765-2616, 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
September 1, 2005
Study Completion
January 1, 2007
Last Updated
October 18, 2019
Record last verified: 2019-10