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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01885260
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 18 to 75
* BMI greater than or equal to 25
* HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
* Type 2 Diabetes Mellitus and on stable dose of oral metformin
* Agree to conduct home-based (fasted) blood glucose testing as directed
Exclusion Criteria:
* Clinically significant abnormalities in medical history or physical exam
* Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
* History of renal transplantation or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Use of oral anti-diabetic medication other than metformin within 3 months of screening
* History of diabetic ketoacidosis
* Any other significant illness or condition that may interfere with the patient participating or completing the study
* Inability or unwillingness to comply with protocol or study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01885260
Study Brief:
Protocol Section:
NCT01885260