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 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT01165268
Eligibility Criteria:
Inclusion criteria for T2DM
* Diagnosis of T2DM
* Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin
* Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration
* Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%
Inclusion criteria for healthy subjects:
* Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)
Inclusion criteria for all subjects:
* Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion \< 300 mg/g creatinine)
* Body Mass Index (BMI) of 18 to 38 kg/m²
* Men and women, ages 18 to 65 years, inclusive
Exclusion criteria for all subjects:
* Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus
* Subjects with T2DM with fasting plasma glucose \> 200 mg/dL, healthy subjects with fasting plasma glucose \> 105 mg/dL
* Subjects with T2DM with HbA1C \> 10.0%, healthy subjects with HbA1C \> 6.8%
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01165268
Study Brief:
Protocol Section:
NCT01165268