MedTrace Logo

Bexagliflozin Efficacy and Safety Trial

NCT02558296 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2021-07-14

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Bexagliflozin

20 mg, tablet

DRUG

Placebo

20 mg tablet to match active comparator

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • J. Paul Lock, MD · Theracos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-08-31
Completion
2019-10-23

Countries

  • Canada
  • Czechia
  • Denmark
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Taiwan
  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02558296 on ClinicalTrials.gov