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NCT04620590 · ClinicalTrials.gov registry record · Phase 4
Dapagliflozin Treatment in Type 2 Diabetes
A Phase 4 study, sponsored by Emerald Clinical.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT04620590 is a Phase 4 study that has completed, run by Emerald Clinical. The registered enrollment target is 17 participants.
The verdict
NCT04620590, a Phase 4 study, has completed, sponsored by Emerald Clinical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. The study will allow for an up to 6-week Screening and Run-in Period, a 2-week Treatment Period and a 5-day Follow-up Period. Patients will consume food from standardized food boxes starting on Day -6 (patients not on insulin) or Day -20 at the earliest (patients on insulin) of the study until Day 18 (inclusive). Eligible patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days starting on Day 1. This will be followed by a Follow-up Period of 5 days.
Interventions
- DRUG Dapagliflozin 10 MG [Farxiga]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-04-20 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04620590
The ClinicalTrials.gov registry entry for NCT04620590 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emerald Clinical, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dapagliflozin 10 MG [Farxiga] is the first listed.
NCT04620590 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04620590 about?
NCT04620590 is a clinical study titled "Dapagliflozin Treatment in Type 2 Diabetes". Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function. It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group. Th...
What is the current status of trial NCT04620590?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2021-04-20. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT04620590?
The interventions under investigation include: Dapagliflozin 10 MG [Farxiga] (DRUG).
Who is sponsoring clinical trial NCT04620590?
This trial is sponsored by Emerald Clinical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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