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Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

NCT03259789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2021-07-07

Study results available
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Summary

The purpose of this study is to investigate the effect of bexagliflozin compared to placebo as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Conditions

  • Type2 Diabetes Mellitus

Interventions

DRUG

Bexagliflozin tablets, 20 mg

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

DRUG

Bexagliflozin tablets, placebo

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

DRUG

Bexagliflozin tablets, 20 mg

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

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • J, Paul Lock, M.D. · Theracos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2019-01-23
Completion
2019-01-23
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

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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 NCT03259789 on ClinicalTrials.gov