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NCT02299388 · ClinicalTrials.gov registry record · Phase 4
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
A Phase 4 study of Diabetes Mellitus, Non-Insulin-Dependent and Hypertensive Disease, sponsored by Tulane University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02299388: Completed Phase 4 study of Diabetes Mellitus, Non-Insulin-Dependent and Hypertensive Disease, sponsored by Tulane University School of Medicine.
NCT02299388 is a Phase 4 study of Diabetes Mellitus, Non-Insulin-Dependent and Hypertensive Disease that has completed, run by Tulane University School of Medicine. The registered enrollment target is 11 participants, below the 242-participant average among 5 other Diabetes Mellitus, Non-Insulin-Dependent trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299388, a Phase 4 study of Diabetes Mellitus, Non-Insulin-Dependent and Hypertensive Disease, has completed, sponsored by Tulane University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators are conducting this research to study the effect of Liraglutide on blood pressure. Several studies have shown increased cardiovascular complications and deaths in diabetics with hypertension. The importance of blood pressure control in diabetes has been shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus is known to reduce blood pressure along with improving diabetes. However, prior research studies with liraglutide have suggested that treatment with liraglutide improves blood pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism behind this effect is yet to be determined.
Primary Outcome
To determine whether Liraglutide lowers systolic BP through the day compared to placebo in patients with T2DM who are not on any anti-hypertensive medications or whose BP medications are unchanged over the study period of 8 weeks.
Conditions Studied
Interventions
- DRUG Liraglutide or Placebo
Study Locations (1)
Louisiana
- Tulane University Health Science Center, Tidewater building and Tulane Hospital and Clinics - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT02299388 record still lists
NCT02299388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 242-participant average among 5 other Diabetes Mellitus, Non-Insulin-Dependent trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Diabetes Mellitus, Non-Insulin-Dependent appearing as the primary indexed condition, and to 1 intervention - of which Liraglutide or Placebo is the first listed.
NCT02299388 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT02299388 about?
NCT02299388 is a clinical study titled "To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study". The investigators are conducting this research to study the effect of Liraglutide on blood pressure. Several studies have shown increased cardiovascular complications and deaths in diabetics with hypertension. The importance of blood pressure control in diabetes has been shown in many clinical trial...
What is the current status of trial NCT02299388?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2014-10. Estimated completion is 2016-12.
What conditions does trial NCT02299388 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Non-Insulin-Dependent, Hypertensive Disease.
What interventions are being tested in trial NCT02299388?
The interventions under investigation include: Liraglutide or Placebo (DRUG).
Who is sponsoring clinical trial NCT02299388?
This trial is sponsored by Tulane University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02299388 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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