Clinical trial NCT03608163: Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
Official title: Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
Conditions: Diabetes Mellitus, Type 1
Hypoglycemia
Hypoglycemia Unawareness
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.
Interventions:
description: Naloxone Nasal Spray
name: Naloxone
other_name: NARCAN Nasal Spray
type: Drug
description: Diazoxide (oral)
name: Diazoxide
type: Drug
description: Sterile water nasal spray
name: Placebo (for Naloxone)
type: Drug
description: Taste matched oral placebo for diazoxide
name: Placebo (for Diazoxide)
type: Drug
Study arms:
design_group_description: Susceptibility to HAAF evaluation: No intervention medication will be given during episodes of hypoglycemia.
design_group_title: No intervention (Susceptibility to HAAF evaluation)
design_group_type: No Intervention
design_group_description: Naloxone evaluation: Intranasal naloxone (4 mg NARCAN Nasal Spray) via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Intranasal naloxone (4 mg NARCAN Nasal Spray) will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
design_group_title: Naloxone
design_group_type: Experimental
design_group_description: Naloxone evaluation: Placebo (for naloxone) nasal spray via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Placebo (for naloxone) nasal spray will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
design_group_title: Placebo (for Naloxone)
design_group_type: Placebo Comparator
design_group_description: Naloxone/Diazoxide evaluation: Up to 7 mg/kg oral diazoxide 3 hours before the first hypoglycemic episode. Intranasal naloxone (4 mg NARCAN Nasal Spray) via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Intranasal naloxone (4 mg NARCAN Nasal Spray) will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
design_group_title: Naloxone + diazoxide
design_group_type: Experimental
design_group_description: Naloxone/Diazoxide evaluation: Up to 7 mg/kg oral diazoxide 3 hours before the first hypoglycemic episode. Placebo (for naloxone) nasal spray via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Placebo (for naloxone) nasal spray will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
design_group_title: Diazoxide + placebo (for naloxone)
design_group_type: Active Comparator
design_group_description: Naloxone/Diazoxide evaluation: Oral placebo (for diazoxide) 3 hours before the first hypoglycemic episode. Intranasal naloxone (4 mg NARCAN Nasal Spray) via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Intranasal naloxone (4 mg NARCAN Nasal Spray) will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
design_group_title: Naloxone + placebo (for diazoxide)
design_group_type: Active Comparator
design_group_description: Naloxone/Diazoxide evaluation: Oral placebo (for diazoxide) 3 hours before the first hypoglycemic episode. Placebo (for naloxone) nasal spray via a nostril twice during the first hypoglycemia episode; once at the start of insulin administration and again after one hour. Placebo (for naloxone) nasal spray will again be given via a nostril twice during the second period of hypoglycemia; once at the start of insulin administration and again after one hour.
design_group_title: Placebo (for naloxone) + placebo (for diazoxide)
design_group_type: Placebo Comparator
Sponsor: Albert Einstein College of Medicine, Inc.
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 二氮嗪
lang: CN
name: Diazoxide
lang: EN
name: ジアゾキシド
lang: JP
name: 盐酸纳洛酮
lang: CN
name: Naloxone hydrochloride
lang: EN
name: ナロキソン塩酸塩
lang: JP