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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-B001 | Other Identifier | Eli Lilly and Company | |
| AMG109 | Other Identifier | Locemia Solutions ULC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug | 3 mg nasal glucagon powder |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Glucose Level Over Time | Glucometer-based measurements of blood glucose after the studied drug administration. The participants' change in blood glucose level from baseline (just prior to dosing or right after the study drug administration) was measured by the caregiver using a glucometer at 15, 30 and 45 minutes after NG administration. The change in glucose was calculated from each time point (15, 30 and 45 minutes) minus the baseline. |
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic | Tallahassee | Florida | 32308 | United States | ||
| Private Clinic |
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Participants and their principal caregiver(s) (such as parents, family member, roommate, teacher, and coach) were trained in the use of nasal glucagon.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Glucagon (NG) | A single dose of 3 mg 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Glucagon (NG) | Nasal glucagon 3 milligram (mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who received at least 1 dose of NG with evaluable treatment response. Events for which participants required external professional medical assistance or used injected glucagon or oral carbohydrates within 30 minutes and before responding were non-evaluable. The good clinical practice (GCP) non-compliant site were also excluded. | Posted | Number | participants | Within 30 minutes after each drug administration for an episode of hypoglycemia |
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All participants who received at least one dose of NG, including GCP non-compliance site.
Adverse events were collected systematically using the Hypoglycemia Questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Glucagon | 3 mg glucagon powder |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
Participants from non-GCP compliant site were excluded from the analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. | Within 2 hours of full recovery from a hypoglycemic event |
| Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia |
| Baltimore |
| Maryland |
| 21229 |
| United States |
| New England Diabetes and Endocrinology Center (NEDEC) | Waltham | Massachusetts | 02451-1136 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|
| OG000 | Nasal Glucagon | Nasal glucagon (NG) 3 mg |
|
|
| Secondary | 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). | Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were excluded. Proportions and n are based on the total number of hypoglycemic events (N=33) of 14 participants; except "Compare to Injectable" is based on 8 events. | Posted | Count of Units | Hypoglycemic Events | After each drug administration for an episode of hypoglycemia | Hypoglycemic Events | Hypoglycemic Events |
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| Secondary | 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. | Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event.Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population. | Posted | Number | percentage of participants | Within 2 hours of full recovery from a hypoglycemic event |
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| Other Pre-specified | Change in Blood Glucose Level Over Time | Glucometer-based measurements of blood glucose after the studied drug administration. The participants' change in blood glucose level from baseline (just prior to dosing or right after the study drug administration) was measured by the caregiver using a glucometer at 15, 30 and 45 minutes after NG administration. The change in glucose was calculated from each time point (15, 30 and 45 minutes) minus the baseline. | Participants received at least 1 dose of the NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population. | Posted | Mean | Standard Deviation | milligram/deciliter (mg/dL) | Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia |
|
|
|
| 0 |
| 22 |
| 20 |
| 22 |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Face Injury | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Headache | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Incomplete Dose Administered | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Questionnaire | Systematic Assessment | Hypoglycemia Questionnaire vocabulary name. |
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| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Paranasal Sinus Hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Product Taste Abnormal | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Watery Eyes | Eye disorders | Questionnaire | Systematic Assessment | Hypoglycemia Questionnaire vocabulary name. |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Difficulty: instructions (Relatively Easy) |
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| Difficulty: instructions (Easy) |
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| Difficulty: instructions (Very Easy) |
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| Difficulty: administering (Average) |
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| Difficulty: administering (Easy) |
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| Difficulty: administering (Very Easy) |
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| Time to administer (<30 seconds) |
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| Time to administer (30-<60 seconds) |
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| Time to administer (1-<2 minutes) |
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| Degree of satisfaction (Average) |
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| Degree of satisfaction (Relatively Easy) |
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| Degree of satisfaction (Easy) |
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| Degree of satisfaction (Very Easy) |
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| Compare to Injectable (Not Applicable) |
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| Compare to Injectable (Much Easier) |
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| Compare to Injectable (Easier) |
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| Compare to Injectable (About the Same) |
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| Ease to teach other (Easy) |
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| Ease to teach other (Very Easy) |
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