Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents

NCT02402933 | Completed Phase 3 Results

• 3 other identifiers: 16423I8R-MC-B001AMG109
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypoglycemia; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration

  Responses to questions completed by the caregiver are used to assess this outcome. An episode of severe hypoglycemia is generally defined as an event associated with severe neuroglycopenia usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose) administered by a third party. In this study moderate hypoglycemia is defined as an episode wherein the child/adolescent with diabetes has symptoms and/or signs of neuroglycopenia and has a blood glucose ≤3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]) based on a blood sample taken at or close to the time of treatment.

  Within 30 minutes after each drug administration for an episode of hypoglycemia

Secondary Outcomes (2)

• Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaire by the Caregiver

  After each drug administration for an episode of hypoglycemia

• Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire

  Within 2 hours of full recovery from a hypoglycemic event

Other Outcomes (1)

• Change in Blood Glucose Level Over Time

  Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia

Study Arms (1)

Nasal Glucagon

EXPERIMENTAL

A single dose of 3mg glucagon nasal powder administered using a nasal powder delivery device for the treatment of moderate or severe hypoglycemic events; a maximum of 4 events per participant during the study.

Drug: Nasal Glucagon

Interventions

Nasal Glucagon DRUG

3 mg nasal glucagon powder

Also known as: Dry-Mist nasal glucagon, AMG504-1, LY900018

Nasal Glucagon

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Private Clinic

Tallahassee, Florida, 32308, United States

Location

Private Clinic

Baltimore, Maryland, 21229, United States

Location

New England Diabetes and Endocrinology Center (NEDEC)

Waltham, Massachusetts, 02451-1136, United States

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Participants from non-GCP compliant site were excluded from the analysis.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 23, 2019
• Results First Posted: June 26, 2017

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (3)