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 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT02211261
Eligibility Criteria:
Inclusion Criteria:
* Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
* Subjects on stable doses of metformin \>/= 1500 mg daily (SAD cohorts) or \>/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
* HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
* Fasting C-peptide \>1.12 ng/mL (SAD cohorts) or \>/= 0.8 mg/mL (MAD cohorts) at screening
Exclusion Criteria:
* History of Type 1 diabetes mellitus
* Evidence of diabetic complications with significant end-organ damage
* History of chronic pancreatitis or at high risk for pancreatitis
* Poorly controlled hypertension
* History of cardiovascular or cerebrovascular event or procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02211261
Study Brief:
Protocol Section:
NCT02211261