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NCT02940379 · ClinicalTrials.gov registry record · Phase 1
A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol
A Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02940379 is a Phase 1 study of Type 2 Diabetes Mellitus that has completed, run by Sanofi. The registered enrollment target is 24 participants, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02940379, a Phase 1 study of Type 2 Diabetes Mellitus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam. Secondary Objective: To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.
Conditions Studied
Interventions
- DRUG midazolam
- DRUG sotagliflozin (SAR439954)
- DRUG metoprolol
Study Locations (1)
Tennessee
- Investigational Site Number 840001 - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-10 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02940379
The ClinicalTrials.gov registry entry for NCT02940379 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which midazolam is the first listed.
NCT02940379 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT02940379 about?
NCT02940379 is a clinical study titled "A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol". Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam. Secondary Objective: To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail pro...
What is the current status of trial NCT02940379?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-10. Estimated completion is 2016-12.
What conditions does trial NCT02940379 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT02940379?
The interventions under investigation include: midazolam (DRUG), sotagliflozin (SAR439954) (DRUG), metoprolol (DRUG).
Who is sponsoring clinical trial NCT02940379?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02940379 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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