Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes. The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.

Key facts

Study ID

NCT01029704

Run by

Theracos

People needed

151

Starts

2009-12-01

Expected to finish

2010-07-01

Last updated by the study team

2021-06-16

Who can join

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

You may qualify if…

• Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
• Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
• HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
• Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
• Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
• If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
• Female subjects must be surgically sterilized or postmenopausal.

You may not qualify if…

• Type 1 diabetes or diabetes treated with insulin injection.
• Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
• Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
• Positive results on screen for drugs of abuse.
• Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
• Previous treatment with EGT0001474 or EGT0001442.

Where it is running

• Research Site #10 — Birmingham, Alabama, United States
• Research Site #04 — National City, California, United States
• Research Site #12 — Denver, Colorado, United States
• Research Site #07 — Miami, Florida, United States
• Research Site #08 — Miami, Florida, United States
• Research Site #06 — Reading, Pennsylvania, United States
• Research Site #11 — DeSoto, Texas, United States
• Research Site #01 — San Antonio, Texas, United States
• Research Site #15 — San Antonio, Texas, United States
• Research Site #03 — Brampton, Ontario, Canada
• Research Site #13 — London, Ontario, Canada
• Research Site #02 — Mississauga, Ontario, Canada

Full record on ClinicalTrials.gov

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