Overview

This trial is active, not recruiting.

Conditions hypoglycemia unawareness, type 1 diabetes
Treatments intra-nasal naloxone, intra-nasal saline
Phase phase 1/phase 2
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date June 2016
End date May 2018
Trial size 18 participants
Trial identifier NCT02700048, CTSI # 22405

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Placebo Comparator)
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
intra-nasal saline
3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
(Experimental)
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
intra-nasal naloxone Narcan
3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps

Primary Outcomes

Measure
within person difference in peak epinephrine during hypoglycemia
time frame: 2 years

Secondary Outcomes

Measure
naloxone pharmacokinetics
time frame: 2 year
naloxone pharmacokinetics
time frame: 2 year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
Principal investigator Amir Moheet, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.