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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT00886366
Eligibility Criteria:
Inclusion Criteria:
* Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
* Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment
Exclusion Criteria:
* Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
* Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
* Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.
* Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT00886366
Study Brief:
Protocol Section:
NCT00886366