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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 120
Updated:6/3/2018
Start Date:September 9, 2014
End Date:September 20, 2016

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A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period 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

Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to
metformin in combination with diet and exercise is superior to sitagliptin added to metformin
in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26
weeks.


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
We found this trial at
38
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Huntington Beach, California 92646
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Morehead City, North Carolina 28557
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