Bexagliflozin Efficacy and Safety Trial (BEST)

July 13, 2021 updated by: Theracos

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1V 4G5
        • Research Site 5006
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Research Site 5013
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site 5015
      • Hamilton, Ontario, Canada, L8L5G8
        • Research Site 5012
      • London, Ontario, Canada, N6A 4V2
        • Research Site 5023
      • Peterborough, Ontario, Canada, K9J 0B2
        • Research Site 5016
      • Sudbury, Ontario, Canada, P3C 5K7
        • Research Site 5005
      • Toronto, Ontario, Canada, M5B 1W8
        • Research Site 5022
      • Toronto, Ontario, Canada, M5G 1XS
        • Research Site 5014
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • Research Site 5008
      • St-Charles-Borromee, Quebec, Canada, J6E 6J2
        • Research Site 5007
      • St. Georges, Quebec, Canada, G5Y4T8
        • Research Site 5009
      • Benesov, Czechia, 256 01
        • Research Site 3116
      • Brandys nad Labem, Czechia, 250 01
        • Research Site 3106
      • Brno, Czechia, 60200
        • Research Site 3107
      • Brno, Czechia, 639 00
        • Research Site 3118
      • Cesky Krumlov, Czechia, 381 01
        • Research Site 3109
      • Havirov, Czechia, 736 01
        • Research Site 3114
      • Hradec Kralove, Czechia, 50005
        • Research Site 3103
      • Krnov, Czechia, 794 01
        • Research Site 3110
      • Kromeriz, Czechia, 767 01
        • Research Site 3102
      • Marianske Lazne, Czechia, 353 01
        • Research Site 3105
      • Plzen, Czechia, 326 00
        • Research Site 3113
      • Praha, Czechia, 128 08
        • Research Site 3104
      • Praha, Czechia, 149 00
        • Research Site 3111
      • Praha, Czechia, 181 00
        • Research Site 3112
      • Uherske Hradiste, Czechia, 686 68
        • Research Site 3115
      • Copenhagen, Denmark, 2100
        • Research Site 6104
      • Copenhagen, Denmark, 2300S
        • Research Site 6103
      • Copenhagen, Denmark, 2400
        • Research Site 6105
      • Busan, Korea, Republic of, 602-739
        • Research Site 7006
      • Gwangju, Korea, Republic of, 501-757
        • Research Site 7002
      • Incheon, Korea, Republic of, 400-711
        • Research Site 7008
    • Gangwon-Do
      • Chuncheon, Gangwon-Do, Korea, Republic of, 200-722
        • Research Site 7007
      • Wonju, Gangwon-Do, Korea, Republic of, 220-701
        • Research Site 7001
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republic of, 431-070
        • Research Site 7004
      • Guri, Gyeonggi-do, Korea, Republic of, 471-701
        • Research Site 7005
      • Aguascalientes, Mexico, 20230
        • Research Site 2011
      • Chihuahua, Mexico, 31217
        • Research Site 2009
      • Mexico, Mexico, 80230
        • Research Site 2014
      • Queretaro, Mexico
        • Research Site 2016
      • Veracruz, Mexico, 91910
        • Research Site 2010
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Research Site 2015
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Research Site 2013
    • Tamaulipas
      • Tampico, Tamaulipas, Mexico, 89000
        • Research Site 2008
    • Yucatan
      • Merida, Yucatan, Mexico, 97218
        • Research Site 2012
      • Amsterdam, Netherlands, 2545CH
        • Research Site 5110
      • Harderwijk, Netherlands, 3844DG
        • Research Site 5113
      • Hertogenbosch, Netherlands, 5223GZ
        • Research Site 5101
      • Hoofddorp, Netherlands
        • Research Site 5112
      • Hoogeveen, Netherlands, 7909AA
        • Research Site 5102
      • Rotterdam, Netherlands, 3O45 PM
        • Research Site 5106
      • Zwijndrecht, Netherlands, 3331EV
        • Research Site 5103
      • Aleksandrow Lodzki, Poland, 95-070
        • Research Site 7122
      • Gdansk, Poland, 80-126
        • Research Site 7113
      • Gdynia, Poland, 81-338
        • Research Site 7119
      • Grodzisk Mazowiecki, Poland, 05-825
        • Research Site 7109
      • Katowice, Poland, 20-060
        • Research Site 7115
      • Katowice, Poland, 40-752
        • Research Site 7106
      • Katowice, Poland, 40-954
        • Research Site 7121
      • Kutno, Poland, 99-300
        • Research Site 7111
      • Lodz, Poland, 90-368
        • Research Site 7104
      • Lodz, Poland, 94-255
        • Research Site 7135
      • Lublin, Poland, 20-362
        • Research Site 7120
      • Olawa, Poland, 55-200
        • Research Site 7108
      • Otwock, Poland, 05-402
        • Research Site 7118
      • Pulawy, Poland, 24-100
        • Research Site 7107
      • Sobotka, Poland, 55-050
        • Research Site 7105
      • Sochaczew, Poland, 96-500
        • Research Site 7112
      • Warsaw, Poland, 00-465
        • Research Site 7123
      • Warszawa, Poland, 01-868
        • Research Site 7117
      • Warszawa, Poland, 04-730
        • Research Site 7116
      • Lomonosov, Russian Federation
        • Research Site 9309
      • Moscow, Russian Federation
        • Research Site 9303
      • Moscow, Russian Federation
        • Research Site 9315
      • Novosibirsk, Russian Federation, 630099
        • Research Site 9314
      • Novosibirsk, Russian Federation, 630099
        • Research Site 9318
      • Novosibirsk, Russian Federation
        • Research Site 9301
      • Saint Petersburg, Russian Federation, 1199044
        • Research Site 9310
      • Saint Petersburg, Russian Federation
        • Research Site 9304
      • Saint Petersburg, Russian Federation
        • Research Site 9307
      • Saint Petersburg, Russian Federation
        • Research Site 9311
      • Saint Petersburg, Russian Federation
        • Research Site 9312
      • Tomsk, Russian Federation, 6340
        • Research Site 9302
      • Kaohsiung, Taiwan, 807
        • Research Site 8001
      • New Taipei, Taiwan, 231
        • Research Site 8002
      • Taichung, Taiwan, 404
        • Research Site 8006
      • Tainan, Taiwan, 704
        • Research Site 8005
      • Taipei, Taiwan, 100
        • Research Site 8007
      • Taipei, Taiwan, 111
        • Research Site 8004
      • Taipei, Taiwan, 112
        • Research Site 8003
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Research Site 1090
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Research Site 1041
    • California
      • Azusa, California, United States, 91773
        • Research Site 1073
      • Concord, California, United States, 94520
        • Research Site 1076
      • Fresno, California, United States, 93720
        • Research Site 1078
      • Harbor City, California, United States, 90710
        • Research Site 1089
      • Lincoln, California, United States, 95821
        • Research Site 1058
      • Los Angeles, California, United States, 90022
        • Research Site 1051
      • Los Angeles, California, United States, 90057
        • Research Site 1004
      • Montclair, California, United States, 91763
        • Research Site 1068
      • Orange, California, United States, 92868
        • Research Site 1077
    • Colorado
      • Denver, Colorado, United States, 80209
        • Research Site 1218
      • Golden, Colorado, United States, 80401
        • Research Site 1092
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Research Site 1216
    • Delaware
      • Newark, Delaware, United States, 19713
        • Research Site 1083
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Research Site 1057
      • Brooksville, Florida, United States, 34601
        • Research Site 1059
      • Panama City, Florida, United States, 32401
        • Research Site 1050
      • Port Charlotte, Florida, United States, 33952
        • Research Site 1099
      • Tampa, Florida, United States, 33634
        • Research Site 1066
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Research Site 1072
    • Idaho
      • Pocatello, Idaho, United States, 83201
        • Research Site 1082
    • Illinois
      • Champaign, Illinois, United States, 61822
        • Research Site 1258
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Research Site 1043
      • Avon, Indiana, United States, 46123
        • Research Site 1071
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site 1086
    • Kentucky
      • Covington, Kentucky, United States, 41011
        • Research Site 1224
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site 1228
      • Baltimore, Maryland, United States, 21202
        • Research Site 1221
      • Hyattsville, Maryland, United States, 20782
        • Research Site 1079
    • Michigan
      • Midland, Michigan, United States, 48670
        • Research Site 1223
      • Petoskey, Michigan, United States, 49770
        • Research Site 1217
      • Ypsilanti, Michigan, United States, 48197
        • Research Site 1254
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • Research Site 1054
      • Saint Louis, Missouri, United States, 63141
        • Research Site 1060
    • Montana
      • Kalispell, Montana, United States, 59901
        • Research Site 1252
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Research Site 1052
      • Omaha, Nebraska, United States, 68198
        • Research Site 1263
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Research Site 1080
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Research Site 1219
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Research Site 1044
    • New York
      • Bronx, New York, United States, 10468
        • Research Site 1264
      • Saratoga Springs, New York, United States, 12866
        • Research Site 1220
      • West Seneca, New York, United States, 14224
        • Research Site 1049
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Research Site 1085
      • Charlotte, North Carolina, United States, 28204
        • Research Site 1074
      • Morehead City, North Carolina, United States, 28557
        • Research Site 1056
      • Wilmington, North Carolina, United States, 28401
        • Research Site 1229
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site 1064
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site 1075
    • Oklahoma
      • Lindsay, Oklahoma, United States, 73052
        • Research Site 1266
      • Oklahoma City, Oklahoma, United States, 73119
        • Research Site 1055
      • Oklahoma City, Oklahoma, United States, 73134
        • Research Site 1265
      • Oklahoma City, Oklahoma, United States, 73135
        • Research Site 1046
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Research Site 1260
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Research Site 1042
    • Texas
      • Austin, Texas, United States, 78758
        • Research Site 1225
      • Dallas, Texas, United States, 75235
        • Research Site 1259
      • Kingwood, Texas, United States, 77339
        • Research Site 1048
      • Lampasas, Texas, United States, 76550
        • Research Site 1070
      • Lewisville, Texas, United States, 75067
        • Research Site 1222
      • North Richland Hills, Texas, United States, 76180
        • Research Site 1081
      • San Antonio, Texas, United States, 78212
        • Research Site 1226
      • San Antonio, Texas, United States, 78218
        • Research Site 1053
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Research Site 1063
    • Virginia
      • Salem, Virginia, United States, 24153
        • Research Site 1230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
20 mg, tablet
Other Names:
  • EGT0001442
  • EGT0001474
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
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
48 weeks
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
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168
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
Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168
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
24 week
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
Duration of study (168 weeks)
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
24 weeks
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
Duration of study (168 weeks)
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
Duration of study (168 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

October 23, 2019

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (ESTIMATE)

September 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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