Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1, Hypoglycemia, Hypoglycemia Unawareness

In brief

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.

Key facts

Study ID

NCT03608163

Run by

Albert Einstein College of Medicine

People needed

4

Starts

2019-01-08

Expected to finish

2019-08-22

Last updated by the study team

2025-09-11

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, non-diabetic subjects 21-55 years old

You may not qualify if…

• 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

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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