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

NCT02769481 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2021-05-27

Study results available
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Summary

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

Conditions

Interventions

DRUG

Bexagliflozin

20 mg, tablet

DRUG

Placebo for Bexagliflozin

inactive tablet to match active comparator bexagliflozin

DRUG

Glimepiride

2, 4 or 6 mg, capsule

DRUG

Placebo for Glimepiride

inactive capsules to match active comparator glimepiride

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • J. Paul Lock, MD · Theracos Sub, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-15
Primary Completion
2019-06-14
Completion
2019-06-14
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

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 NCT02769481 on ClinicalTrials.gov