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NCT03168295 · ClinicalTrials.gov registry record · Phase 4
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
A Phase 4 study of Diabetes Mellitus, Type 2, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03168295: Completed Phase 4 study of Diabetes Mellitus, Type 2, sponsored by The University of Texas Health Science Center at San Antonio.
NCT03168295 is a Phase 4 study of Diabetes Mellitus, Type 2 that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 34 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 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
NCT03168295, a Phase 4 study of Diabetes Mellitus, Type 2, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.
Primary Outcome
Renal transplant subjects with native kidneys intact underwent measurement of EGP with an 8 hour infusion of 3-3H-glucose on 2 separate days with the administration in random order of either dapagliflozin 10mg or placebo after 3 hours of the tracer equilibration period. The equilibration at 3 hours was considered the baseline measurement. Measurement of change in endogenous glucose production was obtained for all subjects.
Conditions Studied
Interventions
- DRUG Dapagliflozin 10mg then Placebo Oral Tablet
- DRUG Placebo Oral Tablet then Dapagliflozin 10mg
Study Locations (1)
Texas
- The University of Texas Health Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-05-15 |
| Phase | Phase 4 |
What the finished NCT03168295 record still lists
NCT03168295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Dapagliflozin 10mg then Placebo Oral Tablet is the first listed.
NCT03168295 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03168295 about?
NCT03168295 is a clinical study titled "PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria". Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which...
What is the current status of trial NCT03168295?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2016-10. Estimated completion is 2019-05-15.
What conditions does trial NCT03168295 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03168295?
The interventions under investigation include: Dapagliflozin 10mg then Placebo Oral Tablet (DRUG), Placebo Oral Tablet then Dapagliflozin 10mg (DRUG).
Who is sponsoring clinical trial NCT03168295?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03168295 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03168295's enrollment target sits among peer trials
34 288th of 348 higher than 57 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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.
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