Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes
Lead Sponsor:
Theracos
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of EG...
Detailed Description
EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the blood by increasi...
Eligibility Criteria
Inclusion
- Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes.
- Body mass Index (BMI) between 18 kg/m2 and 37 kg/m2.
- HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive) while on diabetic medications.
- If taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study.
- Female subjects must be surgically sterilized or postmenopausal.
- Non-smoker for at least 3 months.
- Negative alcohol screen.
Exclusion
- Type 1 diabetes.
- Use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea.
- Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at screening.
- Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- Previous treatment with EGT0001474.
- Vaccination within 30 days prior to the first dose of study medication.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00924053
Start Date
June 1 2009
End Date
July 1 2009
Last Update
June 17 2019
Active Locations (1)
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1
dgd Research Inc., a Cetero Research Company
San Antonio, Texas, United States, 78229