Back to resultsIntra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
Primary Purpose
Hypoglycemia Unawareness, Type 1 Diabetes
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
intra-nasal naloxone
Intra-nasal saline
Sponsored by
About this trial
This is an interventional prevention trial for Hypoglycemia Unawareness focused on measuring type 1 diabetes, hypoglycemia, hypoglycemia unawareness
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Clinical and Translational Science Institute, University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Treatment with intra-nasal Naloxone
Arm Description
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Naloxone Pharmacokinetics
maximum concentration (Cmax)
Naloxone Pharmacokinetics
area under the curve (AUC)
Full Information
NCT ID
NCT02700048
First Posted
February 24, 2016
Last Updated
March 24, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02700048
Brief Title
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
Official Title
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
research grant for the trial was not funded
Study Start Date
June 2016 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia Unawareness, Type 1 Diabetes
Keywords
type 1 diabetes, hypoglycemia, hypoglycemia unawareness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
Arm Title
Treatment with intra-nasal Naloxone
Arm Type
Experimental
Arm Description
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Intervention Type
Drug
Intervention Name(s)
intra-nasal naloxone
Other Intervention Name(s)
Narcan
Intervention Description
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Intervention Type
Drug
Intervention Name(s)
Intra-nasal saline
Intervention Description
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
Primary Outcome Measure Information:
Title
Within Person Difference in Peak Epinephrine During Hypoglycemia
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Naloxone Pharmacokinetics
Description
maximum concentration (Cmax)
Time Frame
2 year
Title
Naloxone Pharmacokinetics
Description
area under the curve (AUC)
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Moheet, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Science Institute, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
We'll reach out to this number within 24 hrs