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NCT02956044 · ClinicalTrials.gov registry record · Phase 1
Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
A Phase 1 study, sponsored by Theracos.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02956044: Completed Phase 1 study, sponsored by Theracos.
NCT02956044 is a Phase 1 study that has completed, run by Theracos. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02956044, a Phase 1 study, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin, glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.
Primary Outcome
Whole venous blood samples of 5 mL were be collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. Pharmacokinetic (PK) blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Cmax was obtained directly from experimental observations.
Interventions
- DRUG Metformin
- DRUG Sitagliptin
- DRUG Glimepiride
- DRUG Bexagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
What the finished NCT02956044 record still lists
NCT02956044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT02956044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02956044 about?
NCT02956044 is a clinical study titled "Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin". The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin, glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how well the study drug is to...
What is the current status of trial NCT02956044?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2016-11. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02956044?
The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), Glimepiride (DRUG), Bexagliflozin (DRUG).
Who is sponsoring clinical trial NCT02956044?
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 NCT02956044's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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