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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBI | Other Identifier | Eli Lilly and Company | |
| 2017-000249-33 | EudraCT Number |
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The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Glucagon | Experimental | Single dose of Nasal Glucagon. |
|
| Intramuscular Glucagon | Active Comparator | Single intramuscular (IM) dose of Glucagon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug | Administered nasally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia | Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration. | Pre-dose up to 30 minutes post each glucagon administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration | |
| PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Mainz | 55116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38444629 | Derived | Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19. | |
| 32514794 | Derived |
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In each period, either 3 milligram (mg) nasal glucagon (NG) or 1 mg intramuscular (IM) Glucagon was administered.
After a wash-out period of at least 1 day (24 hours) from the first period (first visit), participants crossed over to the alternate glucagon treatment in period 2 (second visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | NG 1st/IM Glucagon 2nd | Participants received 3 mg of NG at the first treatment visit followed by 1 mg of IM glucagon at the second treatment visit. |
| FG001 | IM Glucagon 1st/NG 2nd | Participants received 1 mg of IM glucagon at the first treatment visit followed by 3 mg of NG at the second treatment visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Visit of Glucagon Treatment |
|
| |||||||||||||||||||||
| Second Visit for Alternate Glucagon |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucagon | All enrolled participants who received either 3 mg NG or 1 mg IM Glucagon. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia | Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration. | All participants who completed both treatment visits with evaluable data. | Posted | Count of Participants | Participants | Pre-dose up to 30 minutes post each glucagon administration |
|
First dose of study drug (Day 1) until post-study completion (Day 30).
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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 (NG) | Dose of 3 mg nasal glucagon. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2017 | Aug 15, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2017 | Aug 15, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| Intramuscular Glucagon | Drug | Administered IM |
|
|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration |
| PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration |
| PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Neuss | Germany |
| Suico JG, Hovelmann U, Zhang S, Shen T, Bergman B, Sherr J, Zijlstra E, Frier BM, Plum-Morschel L. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Ther. 2020 Jul;11(7):1591-1603. doi: 10.1007/s13300-020-00845-7. Epub 2020 Jun 8. |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kilogram (kg) |
|
| Height | Mean | Standard Deviation | Centimeter (cm) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m2) |
|
| IM Glucagon |
Dose of 1 mg IM glucagon. |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) | All enrolled participants who received at least 1 dose of the study drug with evaluable PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milligrams per deciliter (mg/dL) | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration |
|
|
|
| Secondary | PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | All enrolled participants who received at least 1 dose of the study drug with evaluable PD data. | Posted | Median | Full Range | Hour (hr) | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon | All enrolled participants who received at least 1 dose of the study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per millilitre (pg*hr/mL) | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration |
|
|
|
| Secondary | PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | All enrolled participants who received at least 1 dose of the study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms per millilitre (pg/mL) | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration |
|
|
|
| Secondary | PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | All enrolled participants who received at least 1 dose of the study drug with evaluable PK data. | Posted | Median | Full Range | Hour (hr) | Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration |
|
|
|
| 70 |
| 0 |
| 70 |
| 34 |
| 70 |
| EG001 | Intramuscular (IM) Glucagon | Dose of 1 mg intramuscular glucagon. | 0 | 69 | 0 | 69 | 35 | 69 |
| Ocular discomfort | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |