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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: Clinical Trial Phase 4 study, sponsored by Albert Einstein College of Medicine.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Peak epinephrine levels during the first (during Day 1) and third (During Day 2) hypoglycemic clamp episodes were compared. Blood samples were taken every 15 minutes throughout clamp procedures and analyzed using high performance liquid chromatography to measure epinephrine levels. Peak epinephrine levels during the course of the three clamp procedures over the two days were identified for each participant. Results are summarized and reported by study arm using basic descriptive statistics. A re
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 |
Why NCT03608163 stopped before completion
NCT03608163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Naloxone is the first listed.
NCT03608163 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03608163's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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