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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT02791035
Eligibility Criteria:
Inclusion Criteria:
* Subject who has written informed consent
* Subjects who are diagnosed as type 2 diabetes mellitus
* Subjects who are 20 to 70 years old
* Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
* Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)
Exclusion Criteria:
* Type 1 DM
* Gestational DM
* Diabetic ketoacidosis
* CKD stage 3B-5 (eGFR 45)
* Severe infection, serious trauma, or perioperative period
* Known or suspected hypersensitivity to ipragliflozin
* Symptomatic urogenital infection
* Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
* Under the therapeutic intervention and/or another clinical study using IP drug
* Hepatic disease ( 3 times of upper normal limit of AST or ALT)
* Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia
* Drugs not allowed for concomitant use
* Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
* Insulin within 60 days prior to screening
* Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening
* Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate
* GLP-1 agonist (except for exenatide) within 60 days prior to screening
* Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening
* Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening
* Subjects who are not eligible to the study according to an investigator's decision
* Inability to read the consent form
* Pregnancy, lactation, or plan to get pregnant during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02791035
Study Brief:
Protocol Section:
NCT02791035