Clinical trial NCT00924053: Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes
Official title: A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Lead sponsor: Theracos
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 EGT0001474 given to patients with Type 2 diabetes. The study will also evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.

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 increasing the amount of urine produced. This would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as Type 2 diabetes).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Safety and Tolerability of EGT0001474
timeFrame: 25 days
measure: AUC 0-t
timeFrame: 3 days
measure: AUC0-24
timeFrame: 3 days
measure: AUC Inf
timeFrame: 3 days
measure: Cmax
timeFrame: 3 days
measure: Tmax
timeFrame: 3 days
measure: λz
timeFrame: 3 days
measure: t1/2
timeFrame: 3 days
measure: CL/F
timeFrame: 3 days
measure: Vz/F
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: dgd Research Inc., a Cetero Research Company
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Mason W. Freeman, M.D.
role: STUDY_CHAIR
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