Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes

Theracos

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: EGT0001474

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00924053

THR-1474-C-396

Details and patient eligibility

About

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.

Full 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).

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.