HypoglycemiaPhase 3NCT02171130

Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

A Phase 3 study testing Nasal Glucagon in people with Hypoglycemia and Diabetes Mellitus, run by Eli Lilly and Company at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
What is being tested?: Nasal Glucagon
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 9 sitesin 2 countries
Study dates: May 2014to 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
With a history of type 1 diabetes >1 year
At least 18 years of age but not older than 75 years
Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
For female subjects, a urine pregnancy test must be negative.

Who cannot join

Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

Canada6 sites

IRCM
Montreal, Quebec, H2W 1R7
Centre Hospitalier de l'Université de Québec
Québec, Quebec, G1V 4G2
Centre de recherche d'endocrinologie Godin & St-Pierre
Sherbrooke, Quebec, J1G 5K2
Diabetes Clinic
Smiths Falls, Ontario, K7A 4W8
Applied Medical Informatics Research
Westmount, Quebec, H3Z 1E5
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

United States3 sites

Albany Medical College Division of Community Endocrinology
Albany, New York, 12206
University of Minnesota
Minneapolis, Minnesota, 55455
New England Diabetes and Endocrinology Center (NEDEC)
Waltham, Massachusetts, 02451-1136

Other trials in United States

About this study

Official title: A Multiple Center, Open Label, Prospective, Observational Study to Evaluate the Effectiveness and Ease-of-Use of AMG504-1 Administered in the Home or Work Environments for Treating Episodes of Hypoglycemia in Patients With Type 1 Diabetes

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 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.

The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies.

Conditions: Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
Being tested: Nasal Glucagon
Keywords: Diabetes Mellitus, Hypoglycemia, Glucagon, Anti-glucagon Antibody, Immunogenicity
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 groups in NCT02171130
Study group	Role	What they receive
Nasal glucagon	Experimental	3 mg nasal glucagon powder delivered using a nasal powder dosing device. Receives: Drug: Nasal Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration
Responses to questions completed by the caregiver were used to assess this outcome.
An episode of severe hypoglycemia was defined as an episode wherein the person with diabetes is clinically incapacitated to the point where the person requires third-party assistance to treat the hypoglycemia. An episode of moderate hypoglycemia episode was defined as an episode wherein the person with diabetes was showing signs of neuroglycopenia and had a glucometer reading of approximately 60 milligrams per deciliter (mg/dL) (3.3 millimoles per liter [mmol/L]) or less based on a blood sample taken at or near 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 as Determined by Completion of Questionnaires by the Caregiver
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, Nasal Glucagon is easy to carry and would be willing to carry it, nasal 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 (AEs) Reported 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 nonserious AEs, and all Serious Adverse Events (SAEs), 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.

May 2014Aug 2015

First posted24 Jun 2014 (estimated)
Study startMay 2014
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: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02171130
Sponsor's protocol ID: 16427
Other IDs: I8R-MC-B002, AMG108
Status last verified: Mar 2017
First submitted: 12 Jun 2014
Last updated: 15 Oct 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
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All Hypoglycemia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Center, Open Label, Prospective, Observational Study to Evaluate the Effectiveness and Ease-of-Use of AMG504-1 Administered in the Home or Work Environments for Treating Episodes of Hypoglycemia in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT02171130
Acronym / sponsor ID: 16427
Conditions: Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
Keywords: Diabetes Mellitus, Hypoglycemia, Glucagon, Anti-glucagon Antibody, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Locemia Solutions ULC
Study start: May 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 24 Jun 2014 (estimated)
Results: Posted 15 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of 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 Glucagon3 mg nasal glucagon powder delivered using a nasal powder dosing device.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
With a history of type 1 diabetes >1 year
At least 18 years of age but not older than 75 years
Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).

Key exclusion criteria (2 listed)

Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Use of a 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

Percentage 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 were used to assess this outcome. An episode of severe hypoglycemia was defined as an episode wherein the person with diabetes is clinically incapacitated to the point where the person requires third-party assistance to treat the hypoglycemia. An episode of moderate hypoglycemia episode was defined as an episode wherein the person with diabetes was showing signs of neuroglycopenia and had a glucometer reading of approximately 60 milligrams per deciliter (mg/dL) (3.3 millimoles per liter [mmol/L]) or less based on a blood sample taken at or near the time of treatment.

2 secondary outcomes

Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver
Time frame: After each drug administration for an episode of hypoglycemia
Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire
Time frame: Within 2 hours of full recovery from a hypoglycemic event

Results and safety

Results posted to the registry on 15 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nasal Glucagon (NG)	129	101

Primary outcome: Percentage 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. Number. Unit: percentage of participants

Measure	Nasal Glucagon n = 69
Value	95.7

Population analysed: Enrolled participants received at least 1 dose of the study drug with evaluable hypoglycemic event. Events requiring additional medical assistance or rescue therapy within 30 minutes of study drug administration and participants from a Good Clinical Practice (GCP) non-compliant site were excluded.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: After study drug administration, up to 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nasal Glucagon	1 of 87 (1.1%)	74 of 87 (85.1%)	1 of 87

Limitations and caveats (from the sponsor): Sixteen participants were discontinued early because of a clinical trial material issue which might have led to under-dose. One site was terminated due to GCP non-compliance and five participants were discontinued as a result.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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

RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingPhase 2
Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
Postbariatric Hypoglycemia
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1

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

9 sites in 2 countries: 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 9 sites in 2 countries.

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 6 inclusion and 2 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada, 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 15 Oct 2019). 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?

Percentage 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?

On the ClinicalTrials.gov record for NCT02171130.

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 15 Oct 2019.