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NCT02390050 · ClinicalTrials.gov registry record · Phase 2
A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Theracos.
- Completed
- Registry status
- Phase 2
- Development phase
- 292
- Enrollment target
NCT02390050: Completed Phase 2 study, sponsored by Theracos.
NCT02390050 is a Phase 2 study that has completed, run by Theracos. The registered enrollment target is 292 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02390050, a Phase 2 study, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 292 participants
- Enrollment target
Study Summary
The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.
Primary Outcome
Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and su
Interventions
- DRUG Bexagliflozin tablets
- DRUG Bexagliflozin tablets, placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2015-05-12 |
| Est. Completion | 2016-06-03 |
| Phase | Phase 2 |
What the finished NCT02390050 record still lists
NCT02390050 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 2 interventions - of which Bexagliflozin tablets is the first listed.
NCT02390050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02390050 about?
NCT02390050 is a clinical study titled "A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus". The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) I...
What is the current status of trial NCT02390050?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 292 participants. The study started on 2015-05-12. Estimated completion is 2016-06-03.
What interventions are being tested in trial NCT02390050?
The interventions under investigation include: Bexagliflozin tablets (DRUG), Bexagliflozin tablets, placebo (DRUG).
Who is sponsoring clinical trial NCT02390050?
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 NCT02390050's enrollment target sits among peer trials
292 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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