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Type 2 Diabetes MellitusPhase 3BESTNCT02558296

Bexagliflozin Efficacy and Safety Trial

A Phase 3 study testing Bexagliflozin in people with Type 2 Diabetes Mellitus, run by Theracos at 157 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Bexagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,700 participants
Where
157 sitesin 10 countries
Study dates
Oct 2015to 23 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

157 sites in 10 countries.

157 sites in 10 countries

United States66 sites

  • Research Site 1044

    Albuquerque, New Mexico, 87102

  • Research Site 1043

    Anderson, Indiana, 46011

  • Research Site 1228

    Annapolis, Maryland, 21401

  • Research Site 1072

    Augusta, Georgia, 30909

  • Research Site 1225

    Austin, Texas, 78758

  • Research Site 1071

    Avon, Indiana, 46123

  • Research Site 1073

    Azusa, California, 91773

  • Research Site 1221

    Baltimore, Maryland, 21202

  • Research Site 1057

    Boca Raton, Florida, 33434

  • Research Site 1059

    Brooksville, Florida, 34601

  • Research Site 1258

    Champaign, Illinois, 61822

  • Research Site 1085

    Chapel Hill, North Carolina, 27517

  • Research Site 1074

    Charlotte, North Carolina, 28204

  • Research Site 1076

    Concord, California, 94520

  • Research Site 1224

    Covington, Kentucky, 41011

  • Research Site 1042

    Cumberland, Rhode Island, 02864

  • Research Site 1259

    Dallas, Texas, 75235

  • Research Site 1218

    Denver, Colorado, 80209

  • Research Site 1086

    Des Moines, Iowa, 50314

  • Research Site 1075

    Fargo, North Dakota, 58103

  • Research Site 1078

    Fresno, California, 93720

  • Research Site 1090

    Gilbert, Arizona, 85295

  • Research Site 1092

    Golden, Colorado, 80401

  • Research Site 1089

    Harbor City, California, 90710

  • Research Site 1079

    Hyattsville, Maryland, 20782

  • Research Site 1252

    Kalispell, Montana, 59901

  • Research Site 1048

    Kingwood, Texas, 77339

  • Research Site 1070

    Lampasas, Texas, 76550

  • Research Site 1260

    Lancaster, Pennsylvania, 17601

  • Research Site 1080

    Las Vegas, Nevada, 89123

  • Research Site 1222

    Lewisville, Texas, 75067

  • Research Site 1058

    Lincoln, California, 95821

  • Research Site 1266

    Lindsay, Oklahoma, 73052

  • Research Site 1041

    Little Rock, Arkansas, 72204

  • Research Site 1051

    Los Angeles, California, 90022

  • Research Site 1004

    Los Angeles, California, 90057

  • Research Site 1223

    Midland, Michigan, 48670

  • Research Site 1068

    Montclair, California, 91763

  • Research Site 1056

    Morehead City, North Carolina, 28557

  • Research Site 1083

    Newark, Delaware, 19713

  • Research Site 1081

    North Richland Hills, Texas, 76180

  • Research Site 1216

    Norwalk, Connecticut, 06851

  • Research Site 1055

    Oklahoma City, Oklahoma, 73119

  • Research Site 1265

    Oklahoma City, Oklahoma, 73134

  • Research Site 1046

    Oklahoma City, Oklahoma, 73135

  • Research Site 1052

    Omaha, Nebraska, 68131

  • Research Site 1263

    Omaha, Nebraska, 68198

  • Research Site 1077

    Orange, California, 92868

  • Research Site 1050

    Panama City, Florida, 32401

  • Research Site 1217

    Petoskey, Michigan, 49770

  • Research Site 1082

    Pocatello, Idaho, 83201

  • Research Site 1099

    Port Charlotte, Florida, 33952

  • Research Site 1230

    Salem, Virginia, 24153

  • Research Site 1063

    Salt Lake City, Utah, 84124

  • Research Site 1226

    San Antonio, Texas, 78212

  • Research Site 1053

    San Antonio, Texas, 78218

  • Research Site 1220

    Saratoga Springs, New York, 12866

  • Research Site 1219

    Somerset, New Jersey, 08873

  • Research Site 1054

    St Louis, Missouri, 63136

  • Research Site 1060

    St Louis, Missouri, 63141

  • Research Site 1066

    Tampa, Florida, 33634

  • Research Site 1264

    The Bronx, New York, 10468

  • Research Site 1049

    West Seneca, New York, 14224

  • Research Site 1229

    Wilmington, North Carolina, 28401

  • Research Site 1064

    Winston-Salem, North Carolina, 27103

  • Research Site 1254

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland19 sites

  • Research Site 7122

    Aleksandrów Łódzki, 95-070

  • Research Site 7113

    Gdansk, 80-126

  • Research Site 7119

    Gdynia, 81-338

  • Research Site 7109

    Grodzisk Mazowiecki, 05-825

  • Research Site 7115

    Katowice, 20-060

  • Research Site 7106

    Katowice, 40-752

  • Research Site 7121

    Katowice, 40-954

  • Research Site 7111

    Kutno, 99-300

  • Research Site 7104

    Lodz, 90-368

  • Research Site 7135

    Lodz, 94-255

  • Research Site 7120

    Lublin, 20-362

  • Research Site 7108

    Oława, 55-200

  • Research Site 7118

    Otwock, 05-402

  • Research Site 7107

    Puławy, 24-100

  • Research Site 7105

    Sobótka, 55-050

  • Research Site 7112

    Sochaczew, 96-500

  • Research Site 7123

    Warsaw, 00-465

  • Research Site 7117

    Warsaw, 01-868

  • Research Site 7116

    Warsaw, 04-730

Other trials in Poland

Czechia15 sites

  • Research Site 3116

    Benešov, 256 01

  • Research Site 3106

    Brandýs nad Labem, 250 01

  • Research Site 3107

    Brno, 60200

  • Research Site 3118

    Brno, 639 00

  • Research Site 3109

    Český Krumlov, 381 01

  • Research Site 3114

    Havířov, 736 01

  • Research Site 3103

    Hradec Králové, 50005

  • Research Site 3110

    Krnov, 794 01

  • Research Site 3102

    Kroměříž, 767 01

  • Research Site 3105

    Mariánské Lázně, 353 01

  • Research Site 3113

    Pilsen, 326 00

  • Research Site 3104

    Prague, 128 08

  • Research Site 3111

    Prague, 149 00

  • Research Site 3112

    Prague, 181 00

  • Research Site 3115

    Uherské Hradiště, 686 68

Other trials in Czechia

Canada12 sites

  • Research Site 5015

    Cambridge, Ontario, N1R 6V6

  • Research Site 5008

    Gatineau, Quebec, J8Y 6S8

  • Research Site 5005

    Greater Sudbury, Ontario, P3C 5K7

  • Research Site 5012

    Hamilton, Ontario, L8L5G8

  • Research Site 5023

    London, Ontario, N6A 4V2

  • Research Site 5016

    Peterborough, Ontario, K9J 0B2

  • Research Site 5006

    Québec, G1V 4G5

  • Research Site 5007

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Research Site 5009

    Saint-Georges, Quebec, G5Y4T8

  • Research Site 5022

    Toronto, Ontario, M5B 1W8

  • Research Site 5014

    Toronto, Ontario, M5G 1XS

  • Research Site 5013

    Vancouver, British Columbia, V5Z1M9

Other trials in Canada

Russia12 sites

  • Research Site 9309

    Lomonosov

  • Research Site 9303

    Moscow

  • Research Site 9315

    Moscow

  • Research Site 9314

    Novosibirsk, 630099

  • Research Site 9318

    Novosibirsk, 630099

  • Research Site 9301

    Novosibirsk

  • Research Site 9310

    Saint Petersburg, 1199044

  • Research Site 9304

    Saint Petersburg

  • Research Site 9307

    Saint Petersburg

  • Research Site 9311

    Saint Petersburg

  • Research Site 9312

    Saint Petersburg

  • Research Site 9302

    Tomsk, 6340

Other trials in Russia

Mexico9 sites

  • Research Site 2011

    Aguascalientes, 20230

  • Research Site 2009

    Chihuahua City, 31217

  • Research Site 2013

    Culiacán, Sinaloa, 80230

  • Research Site 2015

    Guadalajara, Jalisco, 44160

  • Research Site 2012

    Mérida, Yucatán, 97218

  • Research Site 2014

    México, 80230

  • Research Site 2016

    Querétaro

  • Research Site 2008

    Tampico, Tamaulipas, 89000

  • Research Site 2010

    Veracruz, 91910

Other trials in Mexico

Netherlands7 sites

  • Research Site 5101

    's-Hertogenbosch, 5223GZ

  • Research Site 5110

    Amsterdam, 2545CH

  • Research Site 5113

    Harderwijk, 3844DG

  • Research Site 5112

    Hoofddorp

  • Research Site 5102

    Hoogeveen, 7909AA

  • Research Site 5106

    Rotterdam, 3O45 PM

  • Research Site 5103

    Zwijndrecht, 3331EV

Other trials in Netherlands

South Korea7 sites

  • Research Site 7004

    Anyang-si, Gyeonggi-do, 431-070

  • Research Site 7006

    Busan, 602-739

  • Research Site 7007

    Chuncheon, Gangwon-do, 200-722

  • Research Site 7005

    Guri-si, Gyeonggi-do, 471-701

  • Research Site 7002

    Gwangju, 501-757

  • Research Site 7008

    Incheon, 400-711

  • Research Site 7001

    Wŏnju, Gangwon-do, 220-701

Other trials in South Korea

Taiwan7 sites

  • Research Site 8001

    Kaohsiung City, 807

  • Research Site 8002

    New Taipei City, 231

  • Research Site 8006

    Taichung, 404

  • Research Site 8005

    Tainan, 704

  • Research Site 8007

    Taipei, 100

  • Research Site 8004

    Taipei, 111

  • Research Site 8003

    Taipei, 112

Other trials in Taiwan

Denmark3 sites

  • Research Site 6104

    Copenhagen, 2100

  • Research Site 6103

    Copenhagen, 2300S

  • Research Site 6105

    Copenhagen, 2400

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Bexagliflozin, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BexagliflozinDrug

    Also called EGT0001442, EGT0001474

    20 mg, tablet

  • PlaceboDrug

    20 mg tablet to match active comparator

Study groups in NCT02558296
Study groupRoleWhat they receive
Bexagliflozin tablets, 20 mgActive comparatorEach subject will receive bexagliflozin 20 mg once daily for the duration of the study.
Receives: Drug: Bexagliflozin
Placebo tabletsPlacebo comparatorEach subject will receive placebo (inactive tablet) once daily for the duration of the study.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c From Baseline to Week 24

    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.

    Measured: 24 weeks

Secondary outcomes (3)

  1. Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin

    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

    Measured: 24 weeks

  2. Change in Body Weight From Baseline to Week 48

    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

    Measured: 48 weeks

  3. Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline

    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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionAug 2018
  4. Study completion23 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02558296
Sponsor's protocol ID
THR-1442-C-476
Acronym
BEST
Status last verified
Jul 2021
First submitted
22 Sep 2015
Last updated
14 Jul 2021
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bexagliflozin in people with Type 2 Diabetes Mellitus, run by Theracos at 157 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Poland, Czechia, Canada, Russia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02558296.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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Bexagliflozin Efficacy and Safety Trial (NCT02558296) | AzTrials