Bexagliflozin Efficacy and Safety Trial

NCT02558296 | Completed Phase 3 Results DMC

• 1 other identifier: THR-1442-C-476
• Study Type: interventional
• Target: 1,700
• Locations: 10 countries
• Sites: 157

Brief 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. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

  24 weeks

Secondary Outcomes (3)

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

  24 weeks

• Change in Body Weight From Baseline to Week 48

  48 weeks

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

  24 weeks

Other Outcomes (7)

• Change in HbA1c From Baseline Over Time

  Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168

• Change in Fasting Plasma Glucose Over Time

  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

  24 week

Study Arms (2)

Bexagliflozin tablets, 20 mg

ACTIVE COMPARATOR

Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.

Drug: Bexagliflozin

Placebo tablets

PLACEBO COMPARATOR

Each subject will receive placebo (inactive tablet) once daily for the duration of the study.

Drug: Placebo

Interventions

Bexagliflozin DRUG

20 mg, tablet

Also known as: EGT0001442, EGT0001474

Bexagliflozin tablets, 20 mg

Placebo DRUG

20 mg tablet to match active comparator

Placebo tablets

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theracos: lead

Study Sites (157)

Research Site 1090

Gilbert, Arizona, 85295, United States

Location

Research Site 1041

Little Rock, Arkansas, 72204, United States

Location

Research Site 1073

Azusa, California, 91773, United States

Location

Research Site 1076

Concord, California, 94520, United States

Location

Research Site 1078

Fresno, California, 93720, United States

Location

Research Site 1089

Harbor City, California, 90710, United States

Location

Research Site 1058

Lincoln, California, 95821, United States

Location

Research Site 1051

Los Angeles, California, 90022, United States

Location

Research Site 1004

Los Angeles, California, 90057, United States

Location

Research Site 1068

Montclair, California, 91763, United States

Location

Research Site 1077

Orange, California, 92868, United States

Location

Research Site 1218

Denver, Colorado, 80209, United States

Location

Research Site 1092

Golden, Colorado, 80401, United States

Location

Research Site 1216

Norwalk, Connecticut, 06851, United States

Location

Research Site 1083

Newark, Delaware, 19713, United States

Location

Research Site 1057

Boca Raton, Florida, 33434, United States

Location

Research Site 1059

Brooksville, Florida, 34601, United States

Location

Research Site 1050

Panama City, Florida, 32401, United States

Location

Research Site 1099

Port Charlotte, Florida, 33952, United States

Location

Research Site 1066

Tampa, Florida, 33634, United States

Location

Research Site 1072

Augusta, Georgia, 30909, United States

Location

Research Site 1082

Pocatello, Idaho, 83201, United States

Location

Research Site 1258

Champaign, Illinois, 61822, United States

Location

Research Site 1043

Anderson, Indiana, 46011, United States

Location

Research Site 1071

Avon, Indiana, 46123, United States

Location

Research Site 1086

Des Moines, Iowa, 50314, United States

Location

Research Site 1224

Covington, Kentucky, 41011, United States

Location

Research Site 1228

Annapolis, Maryland, 21401, United States

Location

Research Site 1221

Baltimore, Maryland, 21202, United States

Location

Research Site 1079

Hyattsville, Maryland, 20782, United States

Location

Research Site 1223

Midland, Michigan, 48670, United States

Location

Research Site 1217

Petoskey, Michigan, 49770, United States

Location

Research Site 1254

Ypsilanti, Michigan, 48197, United States

Location

Research Site 1054

St Louis, Missouri, 63136, United States

Location

Research Site 1060

St Louis, Missouri, 63141, United States

Location

Research Site 1252

Kalispell, Montana, 59901, United States

Location

Research Site 1052

Omaha, Nebraska, 68131, United States

Location

Research Site 1263

Omaha, Nebraska, 68198, United States

Location

Research Site 1080

Las Vegas, Nevada, 89123, United States

Location

Research Site 1219

Somerset, New Jersey, 08873, United States

Location

Research Site 1044

Albuquerque, New Mexico, 87102, United States

Location

Research Site 1220

Saratoga Springs, New York, 12866, United States

Location

Research Site 1264

The Bronx, New York, 10468, United States

Location

Research Site 1049

West Seneca, New York, 14224, United States

Location

Research Site 1085

Chapel Hill, North Carolina, 27517, United States

Location

Research Site 1074

Charlotte, North Carolina, 28204, United States

Location

Research Site 1056

Morehead City, North Carolina, 28557, United States

Location

Research Site 1229

Wilmington, North Carolina, 28401, United States

Location

Research Site 1064

Winston-Salem, North Carolina, 27103, United States

Location

Research Site 1075

Fargo, North Dakota, 58103, United States

Location

Research Site 1266

Lindsay, Oklahoma, 73052, United States

Location

Research Site 1055

Oklahoma City, Oklahoma, 73119, United States

Location

Research Site 1265

Oklahoma City, Oklahoma, 73134, United States

Location

Research Site 1046

Oklahoma City, Oklahoma, 73135, United States

Location

Research Site 1260

Lancaster, Pennsylvania, 17601, United States

Location

Research Site 1042

Cumberland, Rhode Island, 02864, United States

Location

Research Site 1225

Austin, Texas, 78758, United States

Location

Research Site 1259

Dallas, Texas, 75235, United States

Location

Research Site 1048

Kingwood, Texas, 77339, United States

Location

Research Site 1070

Lampasas, Texas, 76550, United States

Location

Research Site 1222

Lewisville, Texas, 75067, United States

Location

Research Site 1081

North Richland Hills, Texas, 76180, United States

Location

Research Site 1226

San Antonio, Texas, 78212, United States

Location

Research Site 1053

San Antonio, Texas, 78218, United States

Location

Research Site 1063

Salt Lake City, Utah, 84124, United States

Location

Research Site 1230

Salem, Virginia, 24153, United States

Location

Research Site 5013

Vancouver, British Columbia, V5Z1M9, Canada

Location

Research Site 5015

Cambridge, Ontario, N1R 6V6, Canada

Location

Research Site 5005

Greater Sudbury, Ontario, P3C 5K7, Canada

Location

Research Site 5012

Hamilton, Ontario, L8L5G8, Canada

Location

Research Site 5023

London, Ontario, N6A 4V2, Canada

Location

Research Site 5016

Peterborough, Ontario, K9J 0B2, Canada

Location

Research Site 5022

Toronto, Ontario, M5B 1W8, Canada

Location

Research Site 5014

Toronto, Ontario, M5G 1XS, Canada

Location

Research Site 5008

Gatineau, Quebec, J8Y 6S8, Canada

Location

Research Site 5007

Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

Location

Research Site 5009

Saint-Georges, Quebec, G5Y4T8, Canada

Location

Research Site 5006

Québec, G1V 4G5, Canada

Location

Research Site 3116

Benešov, 256 01, Czechia

Location

Research Site 3106

Brandýs nad Labem, 250 01, Czechia

Location

Research Site 3107

Brno, 60200, Czechia

Location

Research Site 3118

Brno, 639 00, Czechia

Location

Research Site 3109

Český Krumlov, 381 01, Czechia

Location

Research Site 3114

Havířov, 736 01, Czechia

Location

Research Site 3103

Hradec Králové, 50005, Czechia

Location

Research Site 3110

Krnov, 794 01, Czechia

Location

Research Site 3102

Kroměříž, 767 01, Czechia

Location

Research Site 3105

Mariánské Lázně, 353 01, Czechia

Location

Research Site 3113

Pilsen, 326 00, Czechia

Location

Research Site 3104

Prague, 128 08, Czechia

Location

Research Site 3111

Prague, 149 00, Czechia

Location

Research Site 3112

Prague, 181 00, Czechia

Location

Research Site 3115

Uherské Hradiště, 686 68, Czechia

Location

Research Site 6104

Copenhagen, 2100, Denmark

Location

Research Site 6103

Copenhagen, 2300S, Denmark

Location

Research Site 6105

Copenhagen, 2400, Denmark

Location

Research Site 2015

Guadalajara, Jalisco, 44160, Mexico

Location

Research Site 2013

Culiacán, Sinaloa, 80230, Mexico

Location

Research Site 2008

Tampico, Tamaulipas, 89000, Mexico

Location

Research Site 2012

Mérida, Yucatán, 97218, Mexico

Location

Research Site 2011

Aguascalientes, 20230, Mexico

Location

Research Site 2009

Chihuahua City, 31217, Mexico

Location

Research Site 2014

México, 80230, Mexico

Location

Research Site 2016

Querétaro, Mexico

Location

Research Site 2010

Veracruz, 91910, Mexico

Location

Research Site 5101

's-Hertogenbosch, 5223GZ, Netherlands

Location

Research Site 5110

Amsterdam, 2545CH, Netherlands

Location

Research Site 5113

Harderwijk, 3844DG, Netherlands

Location

Research Site 5112

Hoofddorp, Netherlands

Location

Research Site 5102

Hoogeveen, 7909AA, Netherlands

Location

Research Site 5106

Rotterdam, 3O45 PM, Netherlands

Location

Research Site 5103

Zwijndrecht, 3331EV, Netherlands

Location

Research Site 7122

Aleksandrów Łódzki, 95-070, Poland

Location

Research Site 7113

Gdansk, 80-126, Poland

Location

Research Site 7119

Gdynia, 81-338, Poland

Location

Research Site 7109

Grodzisk Mazowiecki, 05-825, Poland

Location

Research Site 7115

Katowice, 20-060, Poland

Location

Research Site 7106

Katowice, 40-752, Poland

Location

Research Site 7121

Katowice, 40-954, Poland

Location

Research Site 7111

Kutno, 99-300, Poland

Location

Research Site 7104

Lodz, 90-368, Poland

Location

Research Site 7135

Lodz, 94-255, Poland

Location

Research Site 7120

Lublin, 20-362, Poland

Location

Research Site 7118

Otwock, 05-402, Poland

Location

Research Site 7108

Oława, 55-200, Poland

Location

Research Site 7107

Puławy, 24-100, Poland

Location

Research Site 7105

Sobótka, 55-050, Poland

Location

Research Site 7112

Sochaczew, 96-500, Poland

Location

Research Site 7123

Warsaw, 00-465, Poland

Location

Research Site 7117

Warsaw, 01-868, Poland

Location

Research Site 7116

Warsaw, 04-730, Poland

Location

Research Site 9309

Lomonosov, Russia

Location

Research Site 9303

Moscow, Russia

Location

Research Site 9315

Moscow, Russia

Location

Research Site 9314

Novosibirsk, 630099, Russia

Location

Research Site 9318

Novosibirsk, 630099, Russia

Location

Research Site 9301

Novosibirsk, Russia

Location

Research Site 9310

Saint Petersburg, 1199044, Russia

Location

Research Site 9304

Saint Petersburg, Russia

Location

Research Site 9307

Saint Petersburg, Russia

Location

Research Site 9311

Saint Petersburg, Russia

Location

Research Site 9312

Saint Petersburg, Russia

Location

Research Site 9302

Tomsk, 6340, Russia

Location

Research Site 7007

Chuncheon, Gangwon-do, 200-722, South Korea

Location

Research Site 7001

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Research Site 7004

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

Research Site 7005

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

Research Site 7006

Busan, 602-739, South Korea

Location

Research Site 7002

Gwangju, 501-757, South Korea

Location

Research Site 7008

Incheon, 400-711, South Korea

Location

Research Site 8001

Kaohsiung City, 807, Taiwan

Location

Research Site 8002

New Taipei City, 231, Taiwan

Location

Research Site 8006

Taichung, 404, Taiwan

Location

Research Site 8005

Tainan, 704, Taiwan

Location

Research Site 8007

Taipei, 100, Taiwan

Location

Research Site 8004

Taipei, 111, Taiwan

Location

Research Site 8003

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

bexagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Albert Collinson
• Organization: Theracos Sub, LLC

acollinson@theracos.com

(508) 630-2129

Study Officials

• J. Paul Lock, MD

  Theracos

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: October 23, 2019
• Last Updated: July 14, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3); TW (7); US (66); RU (12); CZ (15); CA (12); ME (9); PL (19); KR (7); NL (7)