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

NCT03115112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2021-06-22

Study results available
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Summary

The purpose of this study is to investigate the effect of bexagliflozin compared to sitagliptin 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

tablets containing 20 mg bexagliflozin

DRUG

Sitagliptin

tablets containing 100 mg sitagliptin

DRUG

Placebo for sitagliptin

inactive tablets to match the appearance of sitagliptin tablets

DRUG

Placebo for bexagliflozin

inactive tablets to match the appearance of bexagliflozin tablets

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
2017-10-12
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Hungary
  • Japan
  • 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 NCT03115112 on ClinicalTrials.gov