Bexagliflozin Efficacy and Safety Trial
- Registration Number
- NCT02558296
- Lead Sponsor
- Theracos
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1700
- Subjects with a diagnosis of T2DM
- Subjects who have had a stable treatment regimen for T2DM for the past 3 months
- Subjects who present with at least one of the following 3 histories:
Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems
- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- History of genitourinary tract infections
- Evidence of abnormal liver function
- History of MI, stroke or hospitalization for heart failure in the past 3 months
- Prior kidney transplant or evidence of kidney problems
- Prior or planned pace maker implantation
- Pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo tablets Placebo Each subject will receive placebo (inactive tablet) once daily for the duration of the study. Bexagliflozin tablets, 20 mg Bexagliflozin Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 24 24 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Body Weight From Baseline to Week 48 48 weeks 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
Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline 24 weeks 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
Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin 24 weeks 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
Trial Locations
- Locations (157)
Research Site 1090
🇺🇸Gilbert, Arizona, United States
Research Site 1041
🇺🇸Little Rock, Arkansas, United States
Research Site 1073
🇺🇸Azusa, California, United States
Research Site 1076
🇺🇸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
Scroll for more (147 remaining)Research Site 1090🇺🇸Gilbert, Arizona, United States