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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT04889157
Eligibility Criteria:
Inclusion Criteria:
* Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
* HbA1c greater than or equal to 7% and less than or equal to 10.5%
* Total body weight \>50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m\^2
Exclusion Criteria:
* Any condition possibly affecting drug absorption
* Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
* Any malignancy not considered cured
* Personal or family history of MTC or MEN2, or participants with suspected MTC
* Acute pancreatitis or history of chronic pancreatitis
* Acute gallbladder disease
* Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
* Clinically relevant ECG abnormalities
* Positive urine drug test
* Clinical relevant laboratory tests abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT04889157
Study Brief:
Protocol Section:
NCT04889157