CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 312 enrolled
Drug / intervention
Bexagliflozin +1 moredrug
Likely dose
Bexagliflozin 20 mgAI-extracted
Key inclusion· 7
  • ✓Age ≥20 years, male or non-pregnant female
  • ✓Diagnosed Type 2 Diabetes Mellitus with HbA1c between 7.0 and 10.5% (inclusive) at screening
  • ✓Treatment-naïve or on stable anti-diabetic medications for ≥8 weeks prior to screening
  • ✓eGFR ≥30 and <60 mL/min/1.73 m² at screening and one additional time point 1-12 months prior (moderate renal impairment)
Key exclusion· 18
  • ✕Type 1 Diabetes Mellitus or MODY
  • ✕Hemoglobinopathy affecting HbA1c measurement
  • ✕Frequent symptomatic hypoglycemia (>1 episode per week on average)
  • ✕Genitourinary tract infection within 6 weeks of screening or ≥3 infections in last 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02836873
NCT02836873Phase 3Completed
CompareCT.gov

A Double Blind Placebo Controlled Study to Evaluate the Effect of Bexagliflozin Tablets on Hemoglobin A1c in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment

Theracos·interventional·Posted Jul 19, 2016·Updated Jun 30, 2021

In Brief

A Phase 3 clinical trial evaluating Bexagliflozin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 312 participants across 56 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesFrance, Japan, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 19, 2016
Enrollment StartSep 23, 2016
Primary CompletionJan 11, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.0 years ago

Interventions

Bexagliflozindrug

Bexagliflozin tablet, 20 mg

Placebodrug

Placebo (inactive) tablet to match the active comparator