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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01089569
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects ≥18 and ≤75 years of age
* Clinical diagnosis of type 2 diabetes
* Diabetes duration ≥ 1 year
* HbA1c ≥7.0%
* Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)
Exclusion Criteria:
* Previously treated with insulin or incretin-based therapy
* Treated with a thiazolidinedione within past 6 weeks
* Taken oral or injected prednisone or cortisone medications in the previous 30 days
* Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
* Serum creatinine \>1.4mg/dL (women) or \>1.5 mg/dL (men)
* eGFR (Estimated Glomerular Filtration Rate) \<30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
* ALT(Alanine Transaminase) \> 2x Upper Limit of Normal (ULN)
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
* Currently pregnant or planning pregnancy during the study period
* Unable to follow the study protocol
* Unable to speak, read and write in English
* Uncontrolled hyperglycemia with HbA1c \> 9% on metformin or \>8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
* At the investigator's discretion for other medical or psychological reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01089569
Study Brief:
Protocol Section:
NCT01089569