Phase 3
Completed N=461
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
Source: ClinicalTrials.gov NCT02284893 ↗Enrolled (actual)
461
Serious AEs
4.8%
Results posted
Jun 2018
Primary outcomePrimary: Mean Change in HbA1c — -1.41; -1.07 percentage (%) — p=0.0008
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in HbA1c |
-1.41; -1.07 | 0.0008 sig |
| SECONDARY Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0% |
37.3; 25.1 | 0.0034 sig |
| SECONDARY Mean Change in Total Body Weight |
-1.86; -0.51 | 0.0001 sig |
| SECONDARY Mean Change in Fasting Plasma Glucose (FPG) |
-31.9; -11.0 | 0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT02284893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.