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 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT00628212
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 6.5 - 9.5%
* Patients who were not administered 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 failure, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with serious diabetic complications
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* 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:
NCT00628212
Study Brief:
Protocol Section:
NCT00628212