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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT01026194
Eligibility Criteria:
Inclusion Criteria:
* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 6.5% and 10.0%
* Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Exclusion Criteria:
* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are the excessive alcohol addicts
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01026194
Study Brief:
Protocol Section:
NCT01026194