Bexagliflozin Efficacy and Safety Trial (BEST)

Theracos

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Bexagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02558296

THR-1442-C-476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,700 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,700 participants in 2 patient groups, including a placebo group

Bexagliflozin tablets, 20 mg

Active Comparator group

Description:

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

Treatment:

Drug: Bexagliflozin

Placebo tablets

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo