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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT06399835
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening
* Males or females aged 20-80 years
* Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months
* Body mass index ≥ 23 kg/m²
* Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²
Exclusion Criteria:
* Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
* Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
* Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal)
* Patients with heart failure or a history of heart failure
* Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)
* Patients who have participated in another clinical study within the last 30 days
* Alcohol addiction
* Patients for whom the use of Enavogliflozin or Pioglitazone is contraindicated
* Patients taking other oral hypoglycemic agents or insulin or other investigational drugs
* Patients deemed unsuitable for the study based on the investigator's judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT06399835
Study Brief:
Protocol Section:
NCT06399835