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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-B002 | Other Identifier | Eli Lilly and Company | |
| AMG108 | Other Identifier | Locemia Solutions ULC |
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| Name | Class |
|---|---|
| Locemia Solutions ULC | INDUSTRY |
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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. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal glucagon | Experimental | 3 mg nasal glucagon powder delivered using a nasal powder dosing device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug | 3 mg nasal glucagon powder |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Levels Over Time | The participants' blood glucose level was measured by the caregiver using a glucometer at baseline (just prior to dosing and right after the study drug administration), 15, 30 and 45 minutes after nasal glucagon administration. | Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia |
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| New England Diabetes and Endocrinology Center (NEDEC) | Waltham | Massachusetts | 02451-1136 | United States | ||
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.
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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) were trained in the use of nasal glucagon.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Glucagon (NG) | Nasal Glucagon powder (3 milligram [mg]) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Glucagon | Nasal Glucagon powder (3mg) |
| 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 | 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. | 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. | Posted | Number | percentage of participants | Within 30 minutes after each drug administration for an episode of hypoglycemia |
After study drug administration, up to 6 months.
Adverse events were collected systematically using the Hypoglycemia Questionnaire.
Analysis population included participants with at least one exposure to study drug after hypoglycemic event.
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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 | Nasal Glucagon powder (3mg) | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA (17.1) | Systematic Assessment | This death was due to Klebsiella pneumoniae infection and not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
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.
| 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 (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. | Within 2 hours of full recovery from a hypoglycemic event |
| Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA) | Treatment-Emergent ADA includes treatment-induced ADA ('Not Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer of (1:20) and treatment-boosted ADA (with 'Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer that is at least 4-fold higher than the baseline titer. | Baseline and End of Study (6 months) |
| University of Minnesota |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Albany Medical College Division of Community Endocrinology | Albany | New York | 12206 | United States |
| Winnipeg Clinic | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Diabetes Clinic | Smiths Falls | Ontario | K7A 4W8 | Canada |
| IRCM | Montreal | Quebec | H2W 1R7 | Canada |
| Centre Hospitalier de l'Université de Québec | Québec | Quebec | G1V 4G2 | Canada |
| Centre de recherche d'endocrinologie Godin & St-Pierre | Sherbrooke | Quebec | J1G 5K2 | Canada |
| Applied Medical Informatics Research | Westmount | Quebec | H3Z 1E5 | Canada |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Met Exclusion Criteria |
|
| 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 powder (3mg) |
|
|
| Secondary | 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). | Eligible enrolled participants who experienced at least 1 hypoglycemic event and received at least 1 dose of study drug. Participants from the GCP non-compliant site and participants who were impacted by a clinical material issue which might have led to under-dose, were considered ineligible thus excluded from this population. | Posted | Count of Units | Total Number of Events | After each drug administration for an episode of hypoglycemia | Total Number of Events | Total Number of Events |
|
|
|
| Secondary | 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. | Eligible enrolled participants who experienced at least 1 hypoglycemic event and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Within 2 hours of full recovery from a hypoglycemic event |
|
|
|
| Other Pre-specified | Blood Glucose Levels Over Time | The participants' blood glucose level was measured by the caregiver using a glucometer at baseline (just prior to dosing and right after the study drug administration), 15, 30 and 45 minutes after nasal glucagon administration. | 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 GCP non-compliant site were excluded. | 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 | Total Number of Hypoglycemic Events | Total Number of Hypoglycemic Events |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA) | Treatment-Emergent ADA includes treatment-induced ADA ('Not Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer of (1:20) and treatment-boosted ADA (with 'Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer that is at least 4-fold higher than the baseline titer. | Enrolled participants who had antibody sample at both baseline and post-baseline. | Posted | Number | percentage of participants | Baseline and End of Study (6 months) |
|
|
|
| 87 |
| 1 |
| 87 |
| 74 |
| 87 |
|
| Eye inflammation | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hypoaesthesia eye | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (17.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Pain | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Product taste abnormal | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Questionnaire | Systematic Assessment | Hypoglycemia Questionnaire |
|
| Vomiting | Gastrointestinal disorders | Questionnaire | Systematic Assessment | Hypoglycemia Questionnaire |
|
| Nasal Irritation | Respiratory, thoracic and mediastinal disorders | Questionnaire | Systematic Assessment | Hypoglycemia Questionnaire |
|
| Headache | Nervous system disorders | Questionnaire | Systematic Assessment | Hypoglycemia Questionnaire |
|
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| Title | Measurements |
|---|---|
|
| Difficulty: opening the kit (Easy) |
|
| Difficulty: opening the kit (Very Easy) |
|
| Difficulty: instructions (Very Difficult) |
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| Difficulty: instructions (Average) |
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| 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 (Very Difficult) |
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| Difficulty: administering (Relatively Difficult) |
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| Difficulty: administering (Average) |
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| Difficulty: administering (Relatively Easy) |
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| Difficulty: administering (Easy) |
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| Difficulty: administering (Very Easy) |
|
| 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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| Time to administer (2-<5 minutes) |
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| Degree of satisfaction (Relatively Difficult) |
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| Degree of satisfaction (Average) |
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| Degree of satisfaction (Relatively Easy) |
|
| Degree of satisfaction (Easy) |
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| Degree of satisfaction (Very Easy) |
|
| 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 (Missing) |
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| Ease to teach other (Neither Agree nor Disagree) |
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| Ease to teach other (Somewhat Agree) |
|
| Ease to teach other (Mostly Agree) |
|
| Ease to teach other (Strongly Agree) |
|
| Title | Measurements |
|---|---|
|
| 45 minutes drug administration |
|