Can two old drugs stop a dangerous diabetes complication?
NCT ID NCT03608163
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.
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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
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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 Hide 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
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Other studies related to the condition(s) this trial covers.
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