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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01128894
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
* BMI \>/=20kg/m2 and \</=45 kg/m2
* Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L)
* HbA1c between 7.0% and 10.0%, inclusive
* Female subjects of childbearing potential must be practicing adequate contraception.
Exclusion Criteria:
* History of cancer
* History of treated diabetic gastroparesis
* Current biliary disease or history of pancreatitis
* History of significant GI surgery
* Recent clinically significant cardiovascular and/or cerebrovascular disease
* Hypertension
* History of human immunodeficiency virus infection
* History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
* History of alcohol or substance abuse
* Female subject is pregnant, lactating, or \<6 weeks postpartum
* Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
* History of type 1 diabetes mellitus
* Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
* Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
* History or family history of thyroid disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01128894
Study Brief:
Protocol Section:
NCT01128894