Clinical trial NCT02402933: Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
Official title: A Multiple Center, Open Label, Prospective Study to Evaluate the Effectiveness and Ease-Of-Use of AMG504-1 Administered in the Home or School Environments for Treating Hypoglycemia in Children and Adolescents With T1D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoglycemia
Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 26
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of Nasal Glucagon (LY900018) in treating episodes of hypoglycemia.

Detailed description: This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of moderate or severe hypoglycemia in persons with T1D.

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

Eligibility criteria: Inclusion Criteria:

* Availability for the entire study period.
* Motivated Child/Adolescent with diabetes (C/AWD) and caregiver(s) and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the qualified investigator or designee.
* C/AWD lives with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia.
* Male or female C/AWD with a history of type 1 diabetes \>1 year.
* C/AWD aged of at least 4 years of age but less than 18 years.
* A female C/AWD must meet one of the following criteria:

  a) Participant is of child-bearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the pre-trial evaluation and enrollment visit until study completion). An acceptable method of contraception includes one of the following: (i) Abstinence from heterosexual intercourse (ii) Systemic contraceptives (birth control pills, injectable/implantable/ insertable hormonal birth control products, transdermal patch) (iii) Intrauterine device (iv) Condom with spermicide, OR b) Participant is of non-child-bearing potential, defined as a female who had had a hysterectomy or tubal ligation, is clinically considered infertile or has not yet reached menarche.
* In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a suitable candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations.
* Willingness to adhere to the protocol requirements.

Exclusion Criteria:

* Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or lactating.
* History of significant hypersensitivity to glucagon, or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs.
* Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects.
* Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
* Use of daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
* Concomitant maintenance therapy with any drug that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.
* Regular consumption of 3 or more units of alcoholic beverages per day.
* Current participation in another clinical trial, intent to enroll in another clinical trial during this clinical study or use of an Investigational Product (in another clinical trial) within the prior 30 days.

Primary outcomes:
measure: Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration
timeFrame: Within 30 minutes after each drug administration for an episode of hypoglycemia
Secondary outcomes:
measure: Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaire by the Caregiver
timeFrame: After each drug administration for an episode of hypoglycemia
measure: Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire
timeFrame: Within 2 hours of full recovery from a hypoglycemic event
Other outcomes:
measure: Change in Blood Glucose Level Over Time
timeFrame: Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia
Locations:
city: Tallahassee
country: United States
facility: Private Clinic
state: Florida
city: Baltimore
country: United States
facility: Private Clinic
state: Maryland
city: Waltham
country: United States
facility: New England Diabetes and Endocrinology Center (NEDEC)
state: Massachusetts
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: