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 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT01475734
Eligibility Criteria:
Inclusion Criteria:
* Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
* HbA1c \<10% at Screening for subjects who do not require washout of existing OAD or \<9% at Screening for subjects who do require washout from existing OAD
* Body mass index in range 28 kg/m2 to40 kg/m2
Exclusion Criteria:
* History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
* History of significant gastrointestinal surgery,
* History of significant cardiovascular disease
* History of a seizure disorder
* Documented hypertension or hypotension
* Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
* Current hepatic disease or abnormal liver function tests
* Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2
* History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
* Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
* Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or insulin
* History of type 1 diabetes,
* Prior exposure to GLP-1 agents, including albiglutide
* Blood donation over 500 mL within 8 weeks before Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01475734
Study Brief:
Protocol Section:
NCT01475734