Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

NCT02700048 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 1103M96932
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators intend to enroll 18 individuals to obtain the complete data sets from 15 participants. Expected duration of subject participation is 10-12 weeks. This study will consist of two 2-day intervention visits separated by approximately 8 weeks.

Conditions

Hypoglycemia Unawareness; Type 1 Diabetes

Keywords

type 1 diabetes; hypoglycemia; hypoglycemia unawareness

Outcome Measures

Primary Outcomes (1)

• Within Person Difference in Peak Epinephrine During Hypoglycemia

  Primary endpoint will be the within person difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two; investigators will compare this difference between the two treatment conditions

  2 years

Secondary Outcomes (2)

• Naloxone Pharmacokinetics

  2 year

• Naloxone Pharmacokinetics

  2 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps

Drug: Intra-nasal saline

Treatment with intra-nasal Naloxone

EXPERIMENTAL

3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps

Drug: intra-nasal naloxone

Interventions

intra-nasal naloxone DRUG

3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps

Also known as: Narcan

Treatment with intra-nasal Naloxone

Intra-nasal saline DRUG

3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are capable of giving informed consent.
• Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
• Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

You may not qualify if:

• Women who are pregnant.
• Women who are breastfeeding.
• Subject has a known hypersensitivity to naloxone.
• Subject with hypertension
• Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
• Subject has taken or used any investigational drug or device in the 30 days prior to screening.
• Subject has taken either prescribed or over the counter medication for 48 hours prior to study drug administration on either of the study days, other than hormonal birth control.
• History of narcotic or heroin abuse.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Clinical and Translational Science Institute, University of Minnesota

Minneapolis, Minnesota, 55446, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Amir Moheet
• Organization: University of Minnesota

mohee002@umn.edu

6126249990

Study Officials

• Amir Moheet, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 7, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 27, 2023
• Results First Posted: March 27, 2023

Record last verified: 2023-03

Locations

US (1)