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NCT03608163 · ClinicalTrials.gov registry record · Phase 4
Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
A Phase 4 study, sponsored by Albert Einstein College of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03608163 is a Phase 4 study that was terminated before completion, run by Albert Einstein College of Medicine. The registered enrollment target is 4 participants.
The verdict
NCT03608163, a Phase 4 study, was terminated before completion, sponsored by Albert Einstein College of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with diabetes. Previous studies suggest that two medications, naloxone and diazoxide, may increase the body's ability to respond to episodes of low blood sugar and prevent the development of HAAF (or hypoglycemia unawareness). Only healthy subjects are being recruited for this study. The study has three distinct phases. In the first phase, healthy, non-diabetic individuals who are susceptible to developing HAAF are identified. Only these individuals will be studied in the second and third phases. The second phase of this study evaluates the effect of using a naloxone nasal spray versus a placebo nasal spray in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF. The third phase of this study evaluates the effect of using naloxone nasal spray and diazoxide in combination, compared to naloxone nasal spray plus a placebo (for diazoxide) or diazoxide plus a placebo (for naloxone) in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF.
Interventions
- DRUG Naloxone
- DRUG Diazoxide
- DRUG Placebo (for Naloxone)
- DRUG Placebo (for Diazoxide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03608163
The ClinicalTrials.gov registry entry for NCT03608163 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Naloxone is the first listed.
NCT03608163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03608163 about?
NCT03608163 is a clinical study titled "Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)". The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with diabetes. Previous studies suggest that two medications, naloxone and diazox...
What is the current status of trial NCT03608163?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2019-01-08. Estimated completion is 2019-08-22.
What interventions are being tested in trial NCT03608163?
The interventions under investigation include: Naloxone (DRUG), Diazoxide (DRUG), Placebo (for Naloxone) (DRUG), Placebo (for Diazoxide) (DRUG).
Who is sponsoring clinical trial NCT03608163?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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