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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT00938158
Eligibility Criteria:
Inclusion Criteria:
* normal renal function or renal impairment
* stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of \>200mL/min (cohort 3 only)
* neither pregnant nor lactating
* HbA1c 6-10.5% inclusive
* females of childbearing potential must be practicing adequate contraception.
Exclusion Criteria:
* inability to meet the PK objectives of the study
* history of hypoglycemia unawareness or severe hypoglycemia
* liver function tests greater than or equal to 2 times the ULN
* clinically significant cardiovascular and/or cerebrovascular disease
* positive test results for hepatitis B, hepatitis C, or HIV
* documented hypertension or hypotension at screening
* known hepatic or biliary abnormalities
* current use of sulfonylureas
* active history of tobacco use within 6 months before screening
* donation of blood in excess of 500mL within 56 days before albiglutide dosing
* receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
* previous or current receipt of exenatide or any other GLP-1 agonist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00938158
Study Brief:
Protocol Section:
NCT00938158