Trial · NCT03608163
Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
NCT03608163, Phase 4, Terminated, Albert Einstein College of Medicine; results first posted 2025-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF). Trials, record NCT03608163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03608163
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
- NCT number
- NCT03608163
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 4 participants, actual
- Lead sponsor
- Albert Einstein College of Medicine
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia, Hypoglycemia Unawareness
- Interventions
- Naloxone, Diazoxide, Placebo (for Naloxone), Placebo (for Diazoxide)
- First posted
- 2018-07-31
- Last updated
- 2025-09-11
- Results first posted
- 2025-09-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Peak Epinephrine Levels Between First and Third Hypoglycemic Clamp Episodes | Obtained every 15 minutes during the first and third 2-hour hypoglycemic episodes (on Day 1 and Day 2), crossover visits up to approximately 6 months apart | 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 reduction of \>20% in the average peak epinephrine levels between first and third hypoglycemic clamp episodes will be considered to define HAAF. |
| Secondary | Endogenous Glucose Production (EGP) | Obtained every 15 minutes during the 1st and 3rd 2-hour hypoglycemic episodes (on Day 1 and Day 2), crossover visits up to ~6 months apart. Data from the five timepoints over the final hour of the 1st and 3rd clamp episodes were averaged/reported. | EGP, a measure of the body's production of sugar, was assessed by determining the Glucose Infusion Rate (GIR), an indirect measure of endogenous glucose production, during the first and third hypoglycemic clamp episodes. GIR is reported in cubic centimeters/minute (cc/min) and results are summarized and reported by study arm using basic descriptive statistics. |
| Secondary | Symptoms of Low Blood Sugar | Obtained every 15 minutes during the first and third 2-hour hypoglycemic episodes (on Day 1 and Day 2), crossover visits up to approximately 6 months apart | Symptoms of low blood sugar were assessed during steady state (the last 30 minutes) using the Edinburgh Hypoglycemia Symptom Scale (EHSS). The EHSS questionnaire is comprised 11 key symptoms (sweating, palpitations, shaking, hunger, confusion, drowsiness, odd behavior, speech difficulty, incoordination, nausea, and headache) and asked participants to evaluate these symptoms using an 8-point Likert scale ranging from 0 ("Not at all") to 7 ("Very severe"), for an overall possible range of 0-77 for each patient, such that higher scores are associated with more intense hypoglycemic symptoms. EHSS scores were summed and averaged and reported by study arm using basic descriptive statistics. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Peak Epinephrine Levels Between First and Third Hypoglycemic Clamp Episodes | Obtained every 15 minutes during the first and third 2-hour hypoglycemic episodes (on Day 1 and Day 2), crossover visits up to approximately 6 months apart | pg/mL | MEAN | |
| SECONDARY | Endogenous Glucose Production (EGP) | Obtained every 15 minutes during the 1st and 3rd 2-hour hypoglycemic episodes (on Day 1 and Day 2), crossover visits up to ~6 months apart. Data from the five timepoints over the final hour of the 1st and 3rd clamp episodes were averaged/reported. | GIR data was obtained from 1 participant following Naloxone administration and 3 participants following Placebo administration. | cc/min | MEAN |
| SECONDARY | Symptoms of Low Blood Sugar | Obtained every 15 minutes during the first and third 2-hour hypoglycemic episodes (on Day 1 and Day 2), crossover visits up to approximately 6 months apart | Symptoms of low blood sugar scores were able to be collected from 1 participant following Naloxone administration and 3 participants following Placebo administration. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Peak Epinephrine Levels Between First and Third Hypoglycemic Clamp Episodes | Naloxone | 1st hypoglycemic clamp episode (Day 1) | 372 | Standard Error 134 | pg/mL |
| Comparison of Peak Epinephrine Levels Between First and Third Hypoglycemic Clamp Episodes | Placebo (for Naloxone) | 1st hypoglycemic clamp episode (Day 1) | 707 | Standard Error 195 | pg/mL |
| Comparison of Peak Epinephrine Levels Between First and Third Hypoglycemic Clamp Episodes | Naloxone | 3rd hypoglycemic clamp episode (Day 2) | 397 | Standard Error 168 | pg/mL |
| Comparison of Peak Epinephrine Levels Between First and Third Hypoglycemic Clamp Episodes | Placebo (for Naloxone) | 3rd hypoglycemic clamp episode (Day 2) | 601 | Standard Error 55 | pg/mL |
| Endogenous Glucose Production (EGP) | Naloxone | 1st hypoglycemic clamp episode (Day 1) | 1.6 | Standard Error NA | cc/min |
| Endogenous Glucose Production (EGP) | Placebo (for Naloxone) | 1st hypoglycemic clamp episode (Day 1) | 0.7 | Standard Error 0.2 | cc/min |
| Endogenous Glucose Production (EGP) | Naloxone | 3rd hypoglycemic clamp episode (Day 2) | 0.9 | Standard Error NA | cc/min |
| Endogenous Glucose Production (EGP) | Placebo (for Naloxone) | 3rd hypoglycemic clamp episode (Day 2) | 1.1 | Standard Error 0.3 | cc/min |
| Symptoms of Low Blood Sugar | Naloxone | 1st hypoglycemic clamp episode (Day 1) | 2.0 | Standard Error NA | score on a scale |
| Symptoms of Low Blood Sugar | Placebo (for Naloxone) | 1st hypoglycemic clamp episode (Day 1) | 4.5 | Standard Error 2.1 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1st Intervention (2 Days) | STARTED | Naloxone First, Then Placebo | 2 | |
| 1st Intervention (2 Days) | STARTED | Placebo (for Naloxone), Then Naloxone | 2 | |
| 1st Intervention (2 Days) | COMPLETED | Naloxone First, Then Placebo | 2 | |
| 1st Intervention (2 Days) | COMPLETED | Placebo (for Naloxone), Then Naloxone | 2 | |
| 1st Intervention (2 Days) | NOT COMPLETED | Naloxone First, Then Placebo | 0 | |
| 1st Intervention (2 Days) | NOT COMPLETED | Placebo (for Naloxone), Then Naloxone | 0 | |
| Washout (~6 Months) | STARTED | Naloxone First, Then Placebo | 2 | |
| Washout (~6 Months) | STARTED | Placebo (for Naloxone), Then Naloxone | 2 | |
| Washout (~6 Months) | COMPLETED | Naloxone First, Then Placebo | 2 | |
| Washout (~6 Months) | COMPLETED | Placebo (for Naloxone), Then Naloxone | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naloxone | 0 | 3 |
| Total, all-cause mortality | Placebo (for Naloxone) | 0 | 4 |
| Total, other adverse events | Naloxone | 0 | 3 |
| Total, other adverse events | Placebo (for Naloxone) | 0 | 4 |
| Total, serious adverse events | Naloxone | 0 | 3 |
| Total, serious adverse events | Placebo (for Naloxone) | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK079974 | Mechanisms of hypoglycemia-associated authonomic failure | HAWKINS, MEREDITH A | ALBERT EINSTEIN COLLEGE OF MEDICINE | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Naloxone vs Placebo (for Naloxone): deaths from any cause | Trial comparisons |
| Naloxone vs Placebo (for Naloxone): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03608163
GET https://conductscience.org/api/trials/v1/NCT03608163/registered