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NCT02769481 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
A Phase 3 study, sponsored by Theracos.
- Completed
- Registry status
- Phase 3
- Development phase
- 426
- Enrollment target
NCT02769481: Completed Phase 3 study, sponsored by Theracos.
NCT02769481 is a Phase 3 study that has completed, run by Theracos. The registered enrollment target is 426 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02769481, a Phase 3 study, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 426 participants
- Enrollment target
Study 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).
Primary Outcome
The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).
Interventions
- DRUG Glimepiride
- DRUG Bexagliflozin
- DRUG Placebo for Bexagliflozin
- DRUG Placebo for Glimepiride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2016-08-15 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 3 |
What the finished NCT02769481 record still lists
NCT02769481 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Glimepiride is the first listed.
NCT02769481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02769481 about?
NCT02769481 is a clinical study titled "Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects". 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).
What is the current status of trial NCT02769481?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 426 participants. The study started on 2016-08-15. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT02769481?
The interventions under investigation include: Glimepiride (DRUG), Bexagliflozin (DRUG), Placebo for Bexagliflozin (DRUG), Placebo for Glimepiride (DRUG).
Who is sponsoring clinical trial NCT02769481?
This trial is sponsored by Theracos, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02769481's enrollment target sits among peer trials
426 882nd of 2000 higher than 1,118 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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