Bexagliflozin Efficacy and Safety Trial (BEST)



Status:Active, not recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:40 - Any
Updated:12/21/2018
Start Date:October 2015
End Date:December 2019

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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.

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.

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
We found this trial at
61
sites
Albuquerque, New Mexico 87102
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Albuquerque, NM
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Anderson, Indiana 46011
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Anderson, IN
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Annapolis, Maryland 21401
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Annapolis, MD
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Augusta, Georgia 30909
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Augusta, GA
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13729 Research Boulevard
Austin, Texas 78758
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Austin, TX
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Avon, Indiana 46123
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Avon, IN
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Azusa, California 91773
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Azusa, CA
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Baltimore, Maryland 21202
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Baltimore, MD
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Boca Raton, Florida 33434
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Boca Raton, FL
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Bronx, New York 10468
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Bronx, NY
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Brooksville, Florida 34601
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Brooksville, FL
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Champaign, Illinois 61822
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Champaign, IL
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Chapel Hill, North Carolina 27517
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Chapel Hill, NC
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Charlotte, North Carolina 28204
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Charlotte, NC
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Concord, California 94520
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Concord, CA
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Covington, Kentucky 41011
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Covington, KY
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Cumberland, Rhode Island 02864
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Cumberland, RI
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Dallas, Texas 75230
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Dallas, TX
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Denver, Colorado 80209
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Denver, CO
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Des Moines, Iowa 50314
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Des Moines, IA
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Fargo, North Dakota 58103
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Fargo, ND
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Fresno, California 93720
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Fresno, CA
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Gilbert, Arizona 85295
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Gilbert, AZ
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Golden, Colorado 80401
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Golden, CO
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Harbor City, California 90710
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Harbor City, CA
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Hyattsville, Maryland 20782
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Hyattsville, MD
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Kalispell, Montana 59901
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Kalispell, MT
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Kingwood, Texas 77339
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Kingwood, TX
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Lampasas, Texas 76550
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Lancaster, Pennsylvania 17601
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Lancaster, PA
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Las Vegas, Nevada 89123
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Las Vegas, NV
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Lewisville, Texas 75067
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Lewisville, TX
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Lincoln, California 95821
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Lincoln, CA
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Lindsay, Oklahoma 73052
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Lindsay, OK
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Little Rock, Arkansas 72204
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Little Rock, AR
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Los Angeles, California
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Los Angeles, CA
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Midland, Michigan 48670
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Midland, MI
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Montclair, California 91763
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Montclair, CA
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Morehead City, North Carolina 28557
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Morehead City, NC
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Newark, Delaware 19713
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Newark, DE
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North Richland Hills, Texas 76180
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North Richland Hills, TX
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Norwalk, Connecticut 06851
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Norwalk, CT
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Oklahoma City, Oklahoma 73119
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Oklahoma City, OK
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Omaha, Nebraska 68131
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Omaha, NE
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Orange, California 92868
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Orange, CA
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Panama City, Florida 32401
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Panama City, FL
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Petoskey, Michigan 49770
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Petoskey, MI
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Pocatello, Idaho 83201
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Pocatello, ID
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Port Charlotte, Florida 33952
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Port Charlotte, FL
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41 1st Avenue
Saint Louis, Missouri 63136
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Saint Louis, MO
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Salem, Virginia 24153
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Salem, VA
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436 State Capitol
Salt Lake City, Utah 84101
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Salt Lake City, UT
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San Antonio, Texas 78229
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San Antonio, TX
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Saratoga Springs, New York 12866
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Somerset, New Jersey 08873
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Tampa, Florida 33634
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Tampa, FL
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Vancouver, British Columbia V6T 1Z4
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Vancouver,
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West Seneca, New York 14224
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West Seneca, NY
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Wilmington, North Carolina 28405
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Wilmington, NC
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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Ypsilanti, Michigan 48197
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Ypsilanti, MI
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