Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

NCT ID: NCT02700048

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2021-07-31

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.

Detailed Description

This is a single center, single-blinded randomized cross over design trial, that will compare the impact of IN naloxone vs. IN saline during experimental hypoglycemia on day one on the responses to experimental hypoglycemia on day two. 18 participants will be studied twice, 8 weeks apart. On each occasion participants will undergo a 2 hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the morning of day 2. During the morning clamps, samples will be collected for later measurement of serum epinephrine, glucagon and cortisol levels and participants will be asked to complete a hypoglycemia symptom questionnaire. 3 intranasal doses (4 mg each) of naloxone hydrochloride or IN saline will be administered to the subject on day 1. Plasma will be collected for measurement of naloxone concentrations on day 1 primary outcome is the difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two, thus each participant will have two observations: one from their naloxone experiment and one from their saline experiment.

Secondary endpoint will be naloxone pharmacokinetics including maximum concentration (Cmax), time to maximum concentration (Tmax) and area under the curve (AUC)

Conditions

Hypoglycemia Unawareness; Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Intra-nasal saline

Intervention Type: DRUG

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

Treatment with intra-nasal Naloxone

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

Group Type: EXPERIMENTAL

intra-nasal naloxone

Intervention Type: DRUG

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

Interventions

intra-nasal naloxone

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

Intervention Type: DRUG

Intra-nasal saline

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

Intervention Type: DRUG

Other Intervention Names

Narcan

Eligibility Criteria

Inclusion Criteria

1. Subjects are capable of giving informed consent.

2. 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.

3. 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.

Exclusion Criteria

1. Women who are pregnant.

2. Women who are breastfeeding.

3. Subject has a known hypersensitivity to naloxone.

4. Subject with hypertension

5. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease

6. Subject has taken or used any investigational drug or device in the 30 days prior to screening.

7. 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.

8. History of narcotic or heroin abuse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amir Moheet, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Clinical and Translational Science Institute, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1103M96932

Identifier Type: -

Identifier Source: org_study_id