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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00916604
Eligibility Criteria:
Inclusion Criteria:
* Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
* A body mass index (BMI) of 19 to 27 kg/m2.
* Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
Exclusion Criteria:
* Renal dysfunction GFR \< 60 mL/min.
* Systolic pressure (SBP) \> 160 mmHg or diastolic pressure (DBP) \> 95 mmHg
* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00916604
Study Brief:
Protocol Section:
NCT00916604