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NCT03115112 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Bexagliflozin Compared to Sitagliptin 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
- 386
- Enrollment target
NCT03115112: Completed Phase 3 study, sponsored by Theracos.
NCT03115112 is a Phase 3 study that has completed, run by Theracos. The registered enrollment target is 386 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03115112, a Phase 3 study, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 386 participants
- Enrollment target
Study 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).
Primary Outcome
The primary efficacy objective is to demonstrate that bexagliflozin is non-inferior to sitagliptin by evaluating the treatment effect on hemoglobin A1c (HbA1c) reduction at week 24 in subjects whose type 2 diabetes mellitus (T2DM) is inadequately controlled by metformin.
Interventions
- DRUG Sitagliptin
- DRUG Bexagliflozin
- DRUG Placebo for sitagliptin
- DRUG Placebo for bexagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2017-10-12 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 3 |
What the finished NCT03115112 record still lists
NCT03115112 is an interventional study that assigns participants to a tested intervention. The registered 386 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 (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Sitagliptin is the first listed.
NCT03115112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03115112 about?
NCT03115112 is a clinical study titled "Safety and Efficacy of Bexagliflozin Compared to Sitagliptin 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 sitagliptin 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 NCT03115112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2017-10-12. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT03115112?
The interventions under investigation include: Sitagliptin (DRUG), Bexagliflozin (DRUG), Placebo for sitagliptin (DRUG), Placebo for bexagliflozin (DRUG).
Who is sponsoring clinical trial NCT03115112?
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 NCT03115112's enrollment target sits among peer trials
386 973rd of 2000 higher than 1,026 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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