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Completed

NCT Number: NCT02558296

Bexagliflozin Efficacy and Safety Trial

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site 5013, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bexagliflozin

Drug

20 mg, tablet

Other names: EGT0001442, EGT0001474

Placebo

Drug

20 mg tablet to match active comparator

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Theracos

Industry

Registry information

Official study 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

Acronym: BEST

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 23, 2015
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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