The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.
Approximately 130 investigative sites globally are planned to participate in this study. An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications. The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,700
20 mg, tablet
20 mg tablet to match active comparator
Change in HbA1c From Baseline to Week 24
The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events.
Time frame: 24 weeks
Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin
To evaluate the effect of 20 mg bexagliflozin on the change in HbA1c from baseline to week 24 in randomized subjects who have been prescribed insulin to control their diabetes
Time frame: 24 weeks
Change in Body Weight From Baseline to Week 48
To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48 in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo
Time frame: 48 weeks
Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline
To evaluate the effect of 20 mg bexagliflozin on the change in systolic blood pressure (SBP) from baseline to week 24 in subjects with baseline systolic blood pressure ≥ 140 mmHg compared to placebo
Time frame: 24 weeks
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Research Site 1090
Gilbert, Arizona, United States
Research Site 1041
Little Rock, Arkansas, United States
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Azusa, California, United States
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Concord, California, United States
Research Site 1078
Fresno, California, United States
Research Site 1089
Harbor City, California, United States
Research Site 1058
Lincoln, California, United States
Research Site 1051
Los Angeles, California, United States
Research Site 1004
Los Angeles, California, United States
Research Site 1068
Montclair, California, United States
...and 147 more locations