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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01316094
Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetes mellitus patient
* subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)
* estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and \< 90 mL/min/1.73 m2
* HbA1C value between 6.5 and 8.5%
* body mass index (BMI) 29.0 - 45.0 kg/m2
Exclusion Criteria:
* type 1 diabetes mellitus patients
* proliferative diabetic retinopathy
* subject has received insulin within 12 weeks before the study
* subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic
* serum creatinine \> upper limit of normal
* proteinuria (albumin/creatinine ratio \> 300mg/g)
* dysuria and/or urinary tract infection, genital infection
* significant renal, hepatic or cardiovascular diseases
* severe gastrointestinal diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT01316094
Study Brief:
Protocol Section:
NCT01316094