Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
Status:
Suspended
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Albert Einstein College of Medicine Albert Einstein College of Medicine, Inc.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health (NIH)