Phase 3 Completed N=534 Randomized Triple-blind Treatment

Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

Type 2 Diabetes

Source: ClinicalTrials.gov NCT01606007 ↗

Enrolled (actual)

534

Serious AEs

1.9%

Results posted

Oct 2015

Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 — -0.88; -1.20; -1.47 % HbA1c — p=<0.0001

Summary

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24	-0.88; -1.20; -1.47	<0.0001 sig
SECONDARY Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])	-35.6; -70.4; -79.6	<0.0001 sig
SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-14.0; -31.7; -37.8	—
SECONDARY Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])	18.3; 22.2; 41.4	—
SECONDARY Adjusted Mean Change From Baseline in Body Weight at Week 24	0.00; -2.39; -2.05	—

Eligibility Criteria

Inclusion Criteria

Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
Body mass index (BMI) ≤ 45.0kg/m2

Exclusion Criteria

Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
Hepatic disease
Cardiovascular disease within 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01606007). 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.