Status:
COMPLETED
A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-60 years
Phase:
PHASE1
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 characterise...
Detailed Description
In this study, 30 type 2 diabetic patients requiring oral hypoglycemic therapy with Metformin and/or Thiazolidinedione will be randomized. Twenty (20) patients will be randomized to receive active stu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00239187
Start Date
September 1 2005
End Date
January 1 2007
Last Update
October 18 2019
Active Locations (3)
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1
Profil Institute for Clinical Research Inc.
Chula Vista, California, United States, 91911
2
Clinical Research of West Florida
Clearwater, Florida, United States, 33765-2616
3
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801