Bexagliflozin Efficacy and Safety Trial (BEST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02558296 |
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Recruitment Status :
Completed
First Posted : September 23, 2015
Results First Posted : July 7, 2021
Last Update Posted : July 14, 2021
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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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 2018 |
| Actual Study Completion Date : | October 23, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
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Drug: Bexagliflozin
20 mg, tablet
Other Names:
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Placebo Comparator: Placebo tablets
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
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Drug: Placebo
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 From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin [ Time Frame: 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
- 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 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 [ 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 From Baseline Over Time [ Time Frame: Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168 ]To assess the effect of 20 mg bexagliflozin treatment on the change in HbA1c from baseline versus placebo over time up to 168 weeks
- Change in Fasting Plasma Glucose Over Time [ Time Frame: Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168 ]To evaluate the effect of bexagliflozin treatment on the change in fasting plasma glucose (FPG) versus placebo over time up to 168 weeks
- Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification [ Time Frame: 24 week ]To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period
- Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification [ Time Frame: Duration of study (168 weeks) ]To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study period
- Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent [ Time Frame: 24 weeks ]To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period
- Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent [ Time Frame: Duration of study (168 weeks) ]To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study
- Proportion of Participants With Incidence of Hospitalization for Heart Failure [ Time Frame: Duration of study (168 weeks) ]To measure the incidence of hospitalization for heart failure among all subjects and among subjects who have a history of heart failure at baseline
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558296
Show 157 study locations
| Study Director: | J. Paul Lock, MD | Theracos |
Documents provided by Theracos:
| Responsible Party: | Theracos |
| ClinicalTrials.gov Identifier: | NCT02558296 |
| Other Study ID Numbers: |
THR-1442-C-476 |
| First Posted: | September 23, 2015 Key Record Dates |
| Results First Posted: | July 7, 2021 |
| Last Update Posted: | July 14, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Bexagliflozin Hypoglycemic Agents Physiological Effects of Drugs |