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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT02284893
Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
* Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
* BMI \> 20.0 kg/m2 at the enrollment visit
* Males and Females, age ≥18 years old at time of screening visit
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
* Women must not be breastfeeding
Exclusion Criteria:
* Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
* History of diabetic ketoacidosis
* Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit
* Myocardial infarction
* Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft \[(CABG)\]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty \[(PTCA)\])
* Unstable angina
* Unstable congestive heart failure (CHF)
* Transient ischemic attack (TIA) or significant cerebrovascular disease
* Unstable or previously undiagnosed arrhythmia
* Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%
* Renal Disease
* Hepatic Diseases
* Hematological and Oncological Disease/Conditions
* Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women
* Abnormal Free T4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT02284893
Study Brief:
Protocol Section:
NCT02284893