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NCT02558296 · ClinicalTrials.gov registry record · Phase 3

Bexagliflozin Efficacy and Safety Trial

A Phase 3 study, sponsored by Theracos.

Completed
Registry status
Phase 3
Development phase
1,700
Enrollment target

NCT02558296: Completed Phase 3 study, sponsored by Theracos.

NCT02558296 is a Phase 3 study that has completed, run by Theracos. The registered enrollment target is 1,700 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02558296, a Phase 3 study, has completed, sponsored by Theracos.

COMPLETED
Registry status
Phase 3
Development phase
1,700 participants
Enrollment target

Study Summary

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

Primary Outcome

The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events.

Interventions

  • DRUG Placebo
  • DRUG Bexagliflozin

Trial Details

FieldValue
Enrollment Target 1,700 participants
Start Date 2015-10
Est. Completion 2019-10-23
Phase Phase 3
Theracos

18 total trials

What the finished NCT02558296 record still lists

NCT02558296 is an interventional study that assigns participants to a tested intervention. Its 1,700 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (120% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02558296 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02558296 about?

NCT02558296 is a clinical study titled "Bexagliflozin Efficacy and Safety Trial". The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin st...

What is the current status of trial NCT02558296?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,700 participants. The study started on 2015-10. Estimated completion is 2019-10-23.

What interventions are being tested in trial NCT02558296?

The interventions under investigation include: Placebo (DRUG), Bexagliflozin (DRUG).

Who is sponsoring clinical trial NCT02558296?

This trial is sponsored by Theracos, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02558296's enrollment target sits among peer trials

1,700 132nd of 2000 higher than 1,867 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02558296, the US trial registry maintained by the National Library of Medicine. NCT02558296 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.