Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700048
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Unawareness Type 1 Diabetes Drug: intra-nasal naloxone Drug: Intra-nasal saline Phase 1 Phase 2

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
Study Start Date : June 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Placebo Comparator: Placebo
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
Drug: Intra-nasal saline
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps

Experimental: Treatment with intra-nasal Naloxone
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Drug: intra-nasal naloxone
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Other Name: Narcan




Primary Outcome Measures :
  1. within person difference in peak epinephrine during hypoglycemia [ Time Frame: 2 years ]
    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 :
  1. naloxone pharmacokinetics [ Time Frame: 2 year ]
    maximum concentration (Cmax)

  2. naloxone pharmacokinetics [ Time Frame: 2 year ]
    area under the curve (AUC)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700048


Locations
Layout table for location information
United States, Minnesota
Clinical and Translational Science Institute, University of Minnesota
Minneapolis, Minnesota, United States, 55446
Sponsors and Collaborators
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Amir Moheet, MD University of Minnesota
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02700048    
Other Study ID Numbers: 1103M96932
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
type 1 diabetes
hypoglycemia
hypoglycemia unawareness
Additional relevant MeSH terms:
Layout table for MeSH terms
Unconsciousness
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents