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NCT02973477 · ClinicalTrials.gov registry record · Phase 4
Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)
A Phase 4 study of Type 2 Diabetes and Cardiovascular Diseases, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT02973477: Completed Phase 4 study of Type 2 Diabetes and Cardiovascular Diseases, sponsored by University of Michigan.
NCT02973477 is a Phase 4 study of Type 2 Diabetes and Cardiovascular Diseases that has completed, run by University of Michigan. The registered enrollment target is 45 participants, below the 3,924-participant average among 327 other Type 2 Diabetes 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
NCT02973477, a Phase 4 study of Type 2 Diabetes and Cardiovascular Diseases, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes medication, on measures of nervous system function of the heart in patients with type 2 diabetes. The investigators will compare the effect of dapagliflozin with an active comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart rate variability and assess whether dapagliflozin has modulating effects on measures of nervous system function of the heart. This is a crossover study design where all participants will receive both study medications equally (12-week intervention periods) in a certain order.
Primary Outcome
Heart Rate Variability, as shown by the difference of the LF:HF ratio from baseline to 12 weeks per arm (two 12-week periods with a 2-week washout period. The frequency domain measures \[ low-frequency (LF) power (0.04-0.15 Hz), high-frequency (HF) power (0.15-0.4 Hz), and LF:HF ratio\] are obtained by spectral analysis of R-R interval from continuous electrocardiogram recordings to evaluate for sympathetic/parasympathetic (autonomic nervous function) balance.
Conditions Studied
Interventions
- DRUG Dapagliflozin
- DRUG Glimepiride
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-01-12 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 4 |
What the finished NCT02973477 record still lists
NCT02973477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Dapagliflozin is the first listed.
NCT02973477 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02973477 about?
NCT02973477 is a clinical study titled "Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)". The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes medication, on measures of nervous system function of the heart in patients with type 2 diabetes. The investigators will compare the effect of dapagliflozin with an active comparator, glimepiride (a differe...
What is the current status of trial NCT02973477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2017-01-12. Estimated completion is 2019-08-22.
What conditions does trial NCT02973477 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Cardiovascular Diseases.
What interventions are being tested in trial NCT02973477?
The interventions under investigation include: Dapagliflozin (DRUG), Glimepiride (DRUG).
Who is sponsoring clinical trial NCT02973477?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02973477 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02973477's enrollment target sits among peer trials
45 219th of 327 higher than 108 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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