Bexagliflozin Efficacy and Safety Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02558296

Run by

Theracos

People needed

1700

Starts

2015-10-01

Expected to finish

2019-10-23

Last updated by the study team

2021-07-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Research Site 1041 — Little Rock, Arkansas, United States
• Research Site 1073 — Azusa, California, United States
• Research Site 1076 — Concord, California, United States
• Research Site 1078 — Fresno, California, United States
• Research Site 1089 — Harbor City, California, United States
• Research Site 1058 — Lincoln, California, United States
• Research Site 1051 — Los Angeles, California, United States
• Research Site 1004 — Los Angeles, California, United States
• Research Site 1068 — Montclair, California, United States
• Research Site 1077 — Orange, California, United States
• Research Site 1218 — Denver, Colorado, United States
• Research Site 1092 — Golden, Colorado, United States
• Research Site 1216 — Norwalk, Connecticut, United States
• Research Site 1083 — Newark, Delaware, United States
• Research Site 1057 — Boca Raton, Florida, United States
• Research Site 1059 — Brooksville, Florida, United States
• Research Site 1050 — Panama City, Florida, United States
• Research Site 1099 — Port Charlotte, Florida, United States
• Research Site 1066 — Tampa, Florida, United States
• Research Site 1072 — Augusta, Georgia, United States
• Research Site 1082 — Pocatello, Idaho, United States
• Research Site 1258 — Champaign, Illinois, United States
• Research Site 1043 — Anderson, Indiana, United States
• Research Site 1071 — Avon, Indiana, United States
• Research Site 1090 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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