HypoglycemiaPhase 3NCT02402933
Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
A Phase 3 study testing Nasal Glucagon in people with Hypoglycemia and Diabetes Mellitus, run by Eli Lilly and Company at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Hypoglycemia, Diabetes Mellitus
- What is being tested?
- Nasal Glucagon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2015to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Private Clinic
Baltimore, Maryland, 21229
Private Clinic
Tallahassee, Florida, 32308
New England Diabetes and Endocrinology Center (NEDEC)
Waltham, Massachusetts, 02451-1136
About this study
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
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.
Read the 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.
- Conditions
- Hypoglycemia, Diabetes Mellitus
- Being tested
- Nasal Glucagon
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal GlucagonDrug
Also called Dry-Mist nasal glucagon, AMG504-1, LY900018
3 mg nasal glucagon powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nasal Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assess ease-of-use of intranasal administered glucagon in the hands of caregivers of participants who may be called upon to treat episodes of hypoglycemia.
Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Dry Mist Nasal Glucagon is easy to carry and would be willing to carry it, Intranasal delivery of glucagon is preferable: level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree).
Measured: After each drug administration for an episode of hypoglycemia
Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire
Adverse events solicited through the Nasal Score Questionnaire included: runny nose, nasal congestion (nostrils plugged), nasal itching, sneezing, watery eyes, itchy eyes, redness of eyes, itching of ears, itching of throat, and other.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Within 2 hours of full recovery from a hypoglycemic event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402933
- Sponsor's protocol ID
- 16423
- Other IDs
- I8R-MC-B001, AMG109
- Status last verified
- Sep 2019
- First submitted
- 25 Mar 2015
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02402933
- Acronym / sponsor ID
- 16423
- Conditions
- Hypoglycemia, Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Glucagon | Experimental | Drug: Nasal GlucagonA 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal GlucagonAlso: Dry-Mist nasal glucagon, AMG504-1, LY9000183 mg nasal glucagon powder | Drug | Nasal Glucagon |
Primary outcome
Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration
Time frame: Within 30 minutes after each drug administration for an episode of hypoglycemia
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.
2 secondary outcomes
Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaire by the Caregiver
Time frame: After each drug administration for an episode of hypoglycemia
Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire
Time frame: Within 2 hours of full recovery from a hypoglycemic event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Related trials for Hypoglycemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nasal Glucagon in people with Hypoglycemia and Diabetes Mellitus, run by Eli Lilly and Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration (time frame: Within 30 minutes after each drug administration for an episode of hypoglycemia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.