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

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.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Hypoglycemia Unawareness

Interventions

DRUG

Naloxone

Naloxone Nasal Spray

DRUG

Diazoxide

Diazoxide (oral)

DRUG

Placebo (for Naloxone)

Sterile water nasal spray

DRUG

Placebo (for Diazoxide)

Taste matched oral placebo for diazoxide

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Albert Einstein College of Medicine

  lead OTHER

Principal Investigators

• Meredith Hawkins, MD, MS · Albert Einstein College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-08

Primary Completion

2019-08-22

Completion

2019-08-22

FDA Drug

Yes

Countries

• United States

Study Locations