Clinical trial NCT02558296: Bexagliflozin Efficacy and Safety Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Theracos
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 1700
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin
timeFrame: 24 weeks
measure: Change in Body Weight From Baseline to Week 48
timeFrame: 48 weeks
measure: Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline
timeFrame: 24 weeks
Other outcomes:
measure: Change in HbA1c From Baseline Over Time
timeFrame: Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168
measure: Change in Fasting Plasma Glucose Over Time
timeFrame: Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168
measure: Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification
timeFrame: 24 week
measure: Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification
timeFrame: Duration of study (168 weeks)
measure: Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent
timeFrame: 24 weeks
measure: Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent
timeFrame: Duration of study (168 weeks)
measure: Proportion of Participants With Incidence of Hospitalization for Heart Failure
timeFrame: Duration of study (168 weeks)
Locations:
city: Gilbert
country: United States
facility: Research Site 1090
state: Arizona
city: Little Rock
country: United States
facility: Research Site 1041
state: Arkansas
city: Azusa
country: United States
facility: Research Site 1073
state: California
city: Concord
country: United States
facility: Research Site 1076
state: California
city: Fresno
country: United States
facility: Research Site 1078
state: California
city: Harbor City
country: United States
facility: Research Site 1089
state: California
city: Lincoln
country: United States
facility: Research Site 1058
state: California
city: Los Angeles
country: United States
facility: Research Site 1051
state: California
city: Los Angeles
country: United States
facility: Research Site 1004
state: California
city: Montclair
country: United States
facility: Research Site 1068
state: California
city: Orange
country: United States
facility: Research Site 1077
state: California
city: Denver
country: United States
facility: Research Site 1218
state: Colorado
city: Golden
country: United States
facility: Research Site 1092
state: Colorado
city: Norwalk
country: United States
facility: Research Site 1216
state: Connecticut
city: Newark
country: United States
facility: Research Site 1083
state: Delaware
city: Boca Raton
country: United States
facility: Research Site 1057
state: Florida
city: Brooksville
country: United States
facility: Research Site 1059
state: Florida
city: Panama City
country: United States
facility: Research Site 1050
state: Florida
city: Port Charlotte
country: United States
facility: Research Site 1099
state: Florida
city: Tampa
country: United States
facility: Research Site 1066
state: Florida
city: Augusta
country: United States
facility: Research Site 1072
state: Georgia
city: Pocatello
country: United States
facility: Research Site 1082
state: Idaho
city: Champaign
country: United States
facility: Research Site 1258
state: Illinois
city: Anderson
country: United States
facility: Research Site 1043
state: Indiana
city: Avon
country: United States
facility: Research Site 1071
state: Indiana
city: Des Moines
country: United States
facility: Research Site 1086
state: Iowa
city: Covington
country: United States
facility: Research Site 1224
state: Kentucky
city: Annapolis
country: United States
facility: Research Site 1228
state: Maryland
city: Baltimore
country: United States
facility: Research Site 1221
state: Maryland
city: Hyattsville
country: United States
facility: Research Site 1079
state: Maryland
city: Midland
country: United States
facility: Research Site 1223
state: Michigan
city: Petoskey
country: United States
facility: Research Site 1217
state: Michigan
city: Ypsilanti
country: United States
facility: Research Site 1254
state: Michigan
city: Saint Louis
country: United States
facility: Research Site 1054
state: Missouri
city: Saint Louis
country: United States
facility: Research Site 1060
state: Missouri
city: Kalispell
country: United States
facility: Research Site 1252
state: Montana
city: Omaha
country: United States
facility: Research Site 1052
state: Nebraska
city: Omaha
country: United States
facility: Research Site 1263
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site 1080
state: Nevada
city: Somerset
country: United States
facility: Research Site 1219
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site 1044
state: New Mexico
city: Bronx
country: United States
facility: Research Site 1264
state: New York
city: Saratoga Springs
country: United States
facility: Research Site 1220
state: New York
city: West Seneca
country: United States
facility: Research Site 1049
state: New York
city: Chapel Hill
country: United States
facility: Research Site 1085
state: North Carolina
city: Charlotte
country: United States
facility: Research Site 1074
state: North Carolina
city: Morehead City
country: United States
facility: Research Site 1056
state: North Carolina
city: Wilmington
country: United States
facility: Research Site 1229
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site 1064
state: North Carolina
city: Fargo
country: United States
facility: Research Site 1075
state: North Dakota
city: Lindsay
country: United States
facility: Research Site 1266
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site 1055
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site 1265
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site 1046
state: Oklahoma
city: Lancaster
country: United States
facility: Research Site 1260
state: Pennsylvania
city: Cumberland
country: United States
facility: Research Site 1042
state: Rhode Island
city: Austin
country: United States
facility: Research Site 1225
state: Texas
city: Dallas
country: United States
facility: Research Site 1259
state: Texas
city: Kingwood
country: United States
facility: Research Site 1048
state: Texas
city: Lampasas
country: United States
facility: Research Site 1070
state: Texas
city: Lewisville
country: United States
facility: Research Site 1222
state: Texas
city: North Richland Hills
country: United States
facility: Research Site 1081
state: Texas
city: San Antonio
country: United States
facility: Research Site 1226
state: Texas
city: San Antonio
country: United States
facility: Research Site 1053
state: Texas
city: Salt Lake City
country: United States
facility: Research Site 1063
state: Utah
city: Salem
country: United States
facility: Research Site 1230
state: Virginia
city: Vancouver
country: Canada
facility: Research Site 5013
state: British Columbia
city: Cambridge
country: Canada
facility: Research Site 5015
state: Ontario
city: Hamilton
country: Canada
facility: Research Site 5012
state: Ontario
city: London
country: Canada
facility: Research Site 5023
state: Ontario
city: Peterborough
country: Canada
facility: Research Site 5016
state: Ontario
city: Sudbury
country: Canada
facility: Research Site 5005
state: Ontario
city: Toronto
country: Canada
facility: Research Site 5022
state: Ontario
city: Toronto
country: Canada
facility: Research Site 5014
state: Ontario
city: Gatineau
country: Canada
facility: Research Site 5008
state: Quebec
city: St-Charles-Borromee
country: Canada
facility: Research Site 5007
state: Quebec
city: St. Georges
country: Canada
facility: Research Site 5009
state: Quebec
city: Quebec
country: Canada
facility: Research Site 5006
city: Benesov
country: Czechia
facility: Research Site 3116
city: Brandys nad Labem
country: Czechia
facility: Research Site 3106
city: Brno
country: Czechia
facility: Research Site 3107
city: Brno
country: Czechia
facility: Research Site 3118
city: Cesky Krumlov
country: Czechia
facility: Research Site 3109
city: Havirov
country: Czechia
facility: Research Site 3114
city: Hradec Kralove
country: Czechia
facility: Research Site 3103
city: Krnov
country: Czechia
facility: Research Site 3110
city: Kromeriz
country: Czechia
facility: Research Site 3102
city: Marianske Lazne
country: Czechia
facility: Research Site 3105
city: Plzen
country: Czechia
facility: Research Site 3113
city: Praha
country: Czechia
facility: Research Site 3104
city: Praha
country: Czechia
facility: Research Site 3111
city: Praha
country: Czechia
facility: Research Site 3112
city: Uherske Hradiste
country: Czechia
facility: Research Site 3115
city: Copenhagen
country: Denmark
facility: Research Site 6104
city: Copenhagen
country: Denmark
facility: Research Site 6103
city: Copenhagen
country: Denmark
facility: Research Site 6105
city: Chuncheon
country: Korea, Republic of
facility: Research Site 7007
state: Gangwon-Do
city: Wonju
country: Korea, Republic of
facility: Research Site 7001
state: Gangwon-Do
city: Anyang
country: Korea, Republic of
facility: Research Site 7004
state: Gyeonggi-do
city: Guri
country: Korea, Republic of
facility: Research Site 7005
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Research Site 7006
city: Gwangju
country: Korea, Republic of
facility: Research Site 7002
city: Incheon
country: Korea, Republic of
facility: Research Site 7008
city: Guadalajara
country: Mexico
facility: Research Site 2015
state: Jalisco
city: Culiacan
country: Mexico
facility: Research Site 2013
state: Sinaloa
city: Tampico
country: Mexico
facility: Research Site 2008
state: Tamaulipas
city: Merida
country: Mexico
facility: Research Site 2012
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Research Site 2011
city: Chihuahua
country: Mexico
facility: Research Site 2009
city: Mexico
country: Mexico
facility: Research Site 2014
city: Queretaro
country: Mexico
facility: Research Site 2016
city: Veracruz
country: Mexico
facility: Research Site 2010
city: Amsterdam
country: Netherlands
facility: Research Site 5110
city: Harderwijk
country: Netherlands
facility: Research Site 5113
city: Hertogenbosch
country: Netherlands
facility: Research Site 5101
city: Hoofddorp
country: Netherlands
facility: Research Site 5112
city: Hoogeveen
country: Netherlands
facility: Research Site 5102
city: Rotterdam
country: Netherlands
facility: Research Site 5106
city: Zwijndrecht
country: Netherlands
facility: Research Site 5103
city: Aleksandrow Lodzki
country: Poland
facility: Research Site 7122
city: Gdansk
country: Poland
facility: Research Site 7113
city: Gdynia
country: Poland
facility: Research Site 7119
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site 7109
city: Katowice
country: Poland
facility: Research Site 7115
city: Katowice
country: Poland
facility: Research Site 7106
city: Katowice
country: Poland
facility: Research Site 7121
city: Kutno
country: Poland
facility: Research Site 7111
city: Lodz
country: Poland
facility: Research Site 7104
city: Lodz
country: Poland
facility: Research Site 7135
city: Lublin
country: Poland
facility: Research Site 7120
city: Olawa
country: Poland
facility: Research Site 7108
city: Otwock
country: Poland
facility: Research Site 7118
city: Pulawy
country: Poland
facility: Research Site 7107
city: Sobotka
country: Poland
facility: Research Site 7105
city: Sochaczew
country: Poland
facility: Research Site 7112
city: Warsaw
country: Poland
facility: Research Site 7123
city: Warszawa
country: Poland
facility: Research Site 7117
city: Warszawa
country: Poland
facility: Research Site 7116
city: Lomonosov
country: Russian Federation
facility: Research Site 9309
city: Moscow
country: Russian Federation
facility: Research Site 9303
city: Moscow
country: Russian Federation
facility: Research Site 9315
city: Novosibirsk
country: Russian Federation
facility: Research Site 9314
city: Novosibirsk
country: Russian Federation
facility: Research Site 9318
city: Novosibirsk
country: Russian Federation
facility: Research Site 9301
city: Saint Petersburg
country: Russian Federation
facility: Research Site 9310
city: Saint Petersburg
country: Russian Federation
facility: Research Site 9304
city: Saint Petersburg
country: Russian Federation
facility: Research Site 9307
city: Saint Petersburg
country: Russian Federation
facility: Research Site 9311
city: Saint Petersburg
country: Russian Federation
facility: Research Site 9312
city: Tomsk
country: Russian Federation
facility: Research Site 9302
city: Kaohsiung
country: Taiwan
facility: Research Site 8001
city: New Taipei
country: Taiwan
facility: Research Site 8002
city: Taichung
country: Taiwan
facility: Research Site 8006
city: Tainan
country: Taiwan
facility: Research Site 8005
city: Taipei
country: Taiwan
facility: Research Site 8007
city: Taipei
country: Taiwan
facility: Research Site 8004
city: Taipei
country: Taiwan
facility: Research Site 8003
Study officials:
affiliation: Theracos
name: J. Paul Lock, MD
role: STUDY_DIRECTOR
References: