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Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment

NCT02836873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-06-30

Study results available
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Summary

This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM, moderate renal impairment and inadequate glycemic control.

Conditions

Interventions

DRUG

Bexagliflozin

Bexagliflozin tablet, 20 mg

DRUG

Placebo

Placebo (inactive) tablet to match the active comparator

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • Andrew Allegretti, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-23
Primary Completion
2018-01-11
Completion
2018-01-11

Countries

  • United States
  • France
  • Japan
  • Spain

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 NCT02836873 on ClinicalTrials.gov