Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01029704
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01029704
Study Brief:
Protocol Section:
NCT01029704