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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01602003
Eligibility Criteria:
Inclusion Criteria:
1. Patients with Type 2 Diabetes Mellitus
2. Adults between 18 and 75 years of age
3. Patients with HbA1c between 7% and 11%
4. Patients treated with metformin monotherapy for at least 12 weeks and treated with 1000 mg/day or higher dose of metformin for at least 4 weeks right before screening
5. Patients who signed on the consent form after informed on the object, method, and risks of the clinical study
Exclusion Criteria:
1. Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes
2. Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)
3. Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment
4. Patients with NYHA class II-IV congestive heart failure
5. Patients with history of hepatic cirrhosis
6. Patients with renal failure or whose creatinine clearance was less than 60 ml/min
7. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
8. Patients with ALT, AST or CPK exceeding 2.5 times of the upper limit of the normal range
9. Patients with BMI below 20 kg/m2 or exceeding 40 kg/m2
10. Patients with history of asthma or major skin allergy
11. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
12. Patients with history of hypersensitivity to metformin or biguanides.
13. Patients with history of hypersensitivity to thiazolidinediones
14. Patients who took sodium channel blockers in the last 6 weeks prior to Visit 1.
15. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or who took thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1.
16. Patients with other reasons who the investigator decided not to be eligible for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01602003
Study Brief:
Protocol Section:
NCT01602003