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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT01085292
Eligibility Criteria:
Inclusion Criteria:
* Group A: Healthy male and female subjects
* Group B-D: Patients with type 2 diabetes mellitus according to ADA definition; GFR \> 60 mL/min; HbA1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria
Exclusion Criteria:
* History of or presence of clinically significant diseases with the exception of diabetes (Groups B-D)
* Concurrent illness that may affect blood glucose other than diabetes
* Supine blood pressure at screening, after resting for 5 min, of \>140 mmHg systolic or \> 90 mmHg diastolic (Group A) or \> 160 mmHg systolic or \> 95 mmHg in diabetes mellitus patients (Groups B-D)
* Clinically significant abnormal ECG at screening
* Any kidney disease not caused by diabetes or hypertension
* Type 1 diabetes mellitus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01085292
Study Brief:
Protocol Section:
NCT01085292