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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00924053

Run by

Theracos

People needed

24

Starts

2009-06-01

Expected to finish

2009-07-01

Last updated by the study team

2019-06-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• dgd Research Inc., a Cetero Research Company — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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