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Can two old drugs stop a dangerous diabetes complication?

NCT ID NCT03608163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether two medications, naloxone (a nasal spray) and diazoxide (an oral pill), could prevent the body from losing its ability to sense low blood sugar—a condition called hypoglycemia unawareness. Only 4 healthy volunteers were enrolled before the trial was stopped early. The goal was to see if these drugs could boost the body's natural response to low blood sugar episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naloxone and diazoxide
What this could lead to
If successful, this approach could help people with type 1 diabetes maintain their ability to sense low blood sugar, reducing the risk of severe hypoglycemia.
What could go wrong
The trial was terminated early with only 4 participants, so results are very limited. It also tested healthy people, not those with diabetes, so it may not apply to patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

4 people

The number who actually took part.

Started

Jan 2019

Finished

Aug 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: -Healthy, non-diabetic subjects 21-55 years old Exclusion Criteria: * Body Mass Index (BMI) \>35kg/m2 * If Blood Pressure (BP) \>150/90 or \<90/60 on repeated measurements and on more than one occasion * Uncontrolled hyperlipidemia defined as Triglycerides \>400 mg/dL and/or total cholesterol \>300 mg/dL * Clinically significant liver dysfunction: including thrombocytopenia (platelets \<100,000/uL), anemia (as below), hypoalbuminemia (\<3.5 g/dL), coagulopathy (INR \> 1.5), and/or liver enzymes more than 3 times the upper limit of normal * Clinically significant kidney dysfunction: Glomerular Filtration Rate (GFR): \<60 mg/dL * Clinically significant anemia: Prospective subjects with hemoglobin below the lower limit of 12 g/dL for for men and 11 g/dL for women will be assessed with history and physical exam to rule out clinically significant anemia, defined as an individual with symptoms (e.g. fatigue, weakness, shortness of breath, palpitations), signs (pallor, brittle nails etc.), or currently under treatment for anemia. In the absence of a documented hemoglobin decrease or iron deficiency, subjects will not be excluded. * Clinically significant leukocytosis or leukopenia * Clinically significant thrombocytopenia or thrombocytosis * Coagulopathy * Positive drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone, Phencyclidine (PCP). Occasional use of cannabis (not more than twice per week) is not an exclusion. If the test is read as "indeterminate" it will be repeated at the bedside and an additional sample will be sent to the lab. * Use of medications such as beta-blockers or medications that affect counterregulatory response to hypoglycemia * Urinalysis: clinically significant abnormalities * Clinically significant electrolyte abnormalities * Smoking \>10 cigarettes/day * Heavy alcohol use defined as: Men \>14 drinks/week or \> 4 drinks/day, Women \> 7 drinks/week or \> 3 drinks/day * History of chronic liver disease, active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease * Surgeries that involve removal of endocrine glands except for thyroidectomy (if euthyroid on thyroid hormone replacement - if such history Free Thyroxine (fT4) and Thyroid Stimulating Hormone (TSH) will be checked) * Pregnancy * Subject enrolled in another medication intervention study less than one month prior to their anticipated start date in this study besides those done by our group * Family history of diabetes or premature cardiac death in first degree relatives * Allergies to medications administered during study * Uncontrolled psychiatric disorders * Any condition which in the opinion of the PI makes the subject ill-suited for participation in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.