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NCT03167411 · ClinicalTrials.gov registry record · Phase 1
Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection
A Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Theracos.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03167411: Completed Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Theracos.
NCT03167411 is a Phase 1 study of Type 2 Diabetes Mellitus that has completed, run by Theracos. The registered enrollment target is 20 participants, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03167411, a Phase 1 study of Type 2 Diabetes Mellitus, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the drug-drug interaction when given the study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1 receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when administered with exenatide injection.
Primary Outcome
Whole venous blood samples of 3 mL was collected from peripheral vein at 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 of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. Cmax was obtained directly from experimental observations.
Conditions Studied
Interventions
- DRUG Bexagliflozin
- DRUG Exenatide Injection
Study Locations (1)
Indiana
- Clinical Research Site - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 1 |
What the finished NCT03167411 record still lists
NCT03167411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Bexagliflozin is the first listed.
NCT03167411 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT03167411 about?
NCT03167411 is a clinical study titled "Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection". The purpose of this study is to examine the drug-drug interaction when given the study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1 receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug is and how well the study drug is t...
What is the current status of trial NCT03167411?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-05-24. Estimated completion is 2017-06-29.
What conditions does trial NCT03167411 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT03167411?
The interventions under investigation include: Bexagliflozin (DRUG), Exenatide Injection (DRUG).
Who is sponsoring clinical trial NCT03167411?
This trial is sponsored by Theracos, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03167411 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03167411's enrollment target sits among peer trials
20 111th of 130 higher than 17 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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.
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