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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT03076112
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes with HbA1c 7.5% - 9.0% at screening visit
* Male or female between 20 and 75 years of age
* Patients taking sulfonylurea (glimepiride 1\~8mg or gliclazide 30\~120 mg or equivalent dose) and metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
* BMI ≥23 kg/m²
* Estimated GFR ≥ 60 ml/min/1.73m²
* Women of child bearing potential must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must have a negative urinary pregnancy test.
Exclusion Criteria:
* Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
* Patients with acute coronary syndrome within 3 months prior to screening visit
* Patients with acute coronary syndrome within 3 months prior to screening visit
* Pregnant or breastfeeding women or reproductive-age women who refuse contraception
* Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
* Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
* Other clinical trials within 30 days
* Alcohol abuse
* Contraindication to SGLT2 inhibitors or Dipeptidyl-peptidase 4 inhibitors
* Taking insulin, oral hypoglycemic agents other than metformin, sulfonylurea, and the study drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03076112
Study Brief:
Protocol Section:
NCT03076112