Bexagliflozin Efficacy and Safety Trial (BEST) (BEST)
|ClinicalTrials.gov Identifier: NCT02558296|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : August 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Bexagliflozin Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||1700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Placebo Controlled Study to Evaluate the Effects of Bexagliflozin on Hemoglobin A1c in Patients With Type 2 Diabetes and Increased Risk of Cardiovascular Adverse Events|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
20 mg, tablet
Placebo Comparator: Placebo tablets
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
20 mg tablet to match active comparator
- Change in HbA1c from baseline to week 24 [ Time Frame: 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.
- Change in body weight from baseline to week 48 [ Time Frame: 48 weeks ]To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo
- Change in systolic blood pressure from baseline to week 24 [ Time Frame: 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 in HbA1c over time [ Time Frame: Duration of study ]To assess the effect of 20 mg bexagliflozin treatment on the change in HbA1c versus placebo over time
- Change in fasting plasma glucose over time [ Time Frame: Duration of study ]To evaluate the effect of bexagliflozin treatment on the change in fasting plasma glucose (FPG) versus placebo over time
- Proportion of subjects requiring an intensification of anti-diabetic regimen over time [ Time Frame: Duration of study ]To measure the proportion of subjects requiring an intensification of anti-diabetic regimen versus placebo over time
- Proportion of subjects requiring a relaxation of their anti-diabetic regimen over time [ Time Frame: Duration of study ]To measure the proportion of subjects requiring a relaxation of their anti-diabetic regimen versus placebo over time
- Incidence of hospitalization for heart failure [ Time Frame: Duration of study ]To measure the incidence of hospitalization for heart failure among all subjects and among subjects who have a history of heart failure at baseline
- Evaluation of the safety of exposure to bexagliflozin for a minimum of 52 weeks [ Time Frame: At least 52 weeks ]An additional safety objective will be to evaluate the safety of exposure to bexagliflozin for a minimum of 52 weeks in a treatment population that is at elevated risk for major adverse cardiovascular events.
- Bexagliflozin plasma concentration over time for population pharmacokinetics study [ Time Frame: 12 weeks ]As part of an additional pharmacokinetic study, measurement of bexagliflozin plasma concentration as a function of time from dosing (sparsely sampled) will be conducted at 30 sites and will include approximately 240 subjects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558296
|Study Director:||J. Paul Lock, MD||Theracos|