Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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
You may not be if
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
Clareo Health | Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
