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 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT02946632
Eligibility Criteria:
Inclusion Criteria:
* Drug-naïve patients with type 2 diabetes by American Diabetes Association criteria
* HbA1c ≥ 8%, \< 10.5% at screening
* Age ≥ 18 years, \< 65 years
* Body mass index (BMI) ≥ 23 kg/m2, \< 35 kg/m2
* Estimated GFR (eGFR) ≥ 60 ml/min/1.73m2
Exclusion Criteria:
* Uncontrolled hyperglycemia \> 270 mg/dl after an overnight fast
* Diabetic ketoacidosis
* Type 1 diabetes
* Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
* Congestive heart failure (New York Heart Association functional class IV)
* severe hepatic dysfunction (serum levels of either AST, ALT, or alkaline phosphatase above 3 x upper limit of normal (ULN))
* alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
* pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
* use of systemic glucocorticoid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02946632
Study Brief:
Protocol Section:
NCT02946632