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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02768220
Eligibility Criteria:
Inclusion Criteria:
* T2DM
* Age ≥ 18
* glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area
* A1C ≥ 7% any higher limit
* SLGT-2 inhibitor naïve
* On stable doses of current medications for at least 3 months.
Exclusion Criteria:
* Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
* Contraindications to background therapy according to the local label
* Any uncontrolled endocrine disorder except type 2 diabetes
* Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial
o Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner
* Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
* Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02768220
Study Brief:
Protocol Section:
NCT02768220