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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT01733758
Eligibility Criteria:
Inclusion Criteria:
* Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
* Body mass index (BMI) 17 to 40 kg/ m\^2 inclusive
* Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
* Creatinine clearance \>30 mL/min (calculated using the Cockcroft-Gault formula)
Exclusion Criteria:
* History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or \<6 weeks postpartum•
* Clinically significant cardiovascular and/or cerebrovascular disease
* Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
* Serum amylase \>=3 ×ULN and/or serum lipase \>=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
* Prior use of a TZD or GLP-1R agonist within 4 months before Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01733758
Study Brief:
Protocol Section:
NCT01733758