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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT02096705
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
* Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
Inclusion criteria for randomization:
HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
Exclusion Criteria:
* Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
* History of diabetic ketoacidosis of hyperosmolar nonketotic coma
* Clinically diagnosed Type 1 diabetes mellitus
* Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
* Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
* History of unstable or rapidly progressing renal disease
* History of severe hepatobiliary disease
* Mallingancy within 5 years of the screening/enrollment visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02096705
Study Brief:
Protocol Section:
NCT02096705