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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBA | Other Identifier | Eli Lilly and Company | |
| AMG102 | Other Identifier | Locemia Solutions ULC |
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| Name | Class |
|---|---|
| Locemia Solutions ULC | INDUSTRY |
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In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.
The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.
In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Glucagon 1 mg | Experimental | Nasal glucagon (NG) administered as single dose of 1 milligram (mg). |
|
| Nasal Glucagon 2 mg | Experimental | NG administered as single dose of 2 mg. |
|
| SC Glucagon | Active Comparator | Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection. |
|
| Nasal Glucagon 3 mg | Experimental | NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon 1 mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders | Participants with a blood glucose increment of ≥1.5 millimole per liter [mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.](streamdown:incomplete-link) | Pre-dose; 30 minutes following glucagon administration |
| Number of Participants With at Least One Adverse Event | Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Within 3 hours post glucagon administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Baseline-Adjusted Glucose | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration | |
| Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours 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 |
|---|---|---|---|---|---|---|
| Algorithme Pharma | Montreal | Quebec | H3P 3P1 | Canada |
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 were recruited from the clinical site's database and from participants who responded to advertising in local media.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group 1 | Nasal glucagon (NG) dose of 1 milligram (mg) and 2 mg. Subcutaneous (SC) glucagon dose of 1mg. |
| FG001 | Treatment Group 2 | NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg. |
| FG002 | Treatment Group 3 | NG dose of 2 mg and 3mg. SC glucagon dose of 1mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group 1 | NG dose of 1 mg and 2 mg. SC glucagon dose of 1mg. |
| BG001 | Treatment Group 2 | NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Responders | Participants with a blood glucose increment of ≥1.5 millimole per liter [mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.](streamdown:incomplete-link) | All enrolled participants. | Posted | Number | percentage of participants | Pre-dose; 30 minutes following glucagon administration |
|
First dose of study drug (Day 1) until post-study completion (Day 38)
All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
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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 | SC Glucagon | SC glucagon injection 1 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| 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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| ID | Term |
|---|---|
| D005934 | Glucagon |
| D007267 | Injections |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Nasal Glucagon 2 mg | Drug |
|
|
| SC Glucagon | Drug |
|
|
| Nasal Glucagon 3 mg | Drug |
|
|
| Maximum Change From Baseline Concentration (Cmax) of Glucagon | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
| Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
| Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
| BG002 | Treatment Group 3 | NG dose of 2 mg and 3mg. SC glucagon dose of 1mg. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
NG dose of 2 mg
| OG003 | NG 3 mg | NG dose of 3 mg |
|
|
| Primary | Number of Participants With at Least One Adverse Event | Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Participants who received at least one dose of glucagon (SC Glucagon or NG). | Posted | Count of Participants | Participants | No | Within 3 hours post glucagon administration |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Baseline-Adjusted Glucose | Participants who received at least one dose of glucagon (SC Glucagon or NG). | Posted | Mean | Standard Deviation | millimole per liter (mmol/L) | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
|
|
|
| Secondary | Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | Participants who received at least one dose of glucagon (SC Glucagon or NG). | Posted | Median | Full Range | hours (hr) | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
|
|
|
| Secondary | Maximum Change From Baseline Concentration (Cmax) of Glucagon | Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data. | Posted | Mean | Standard Deviation | picograms per millilitre (pg/mL) | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
|
|
|
| Secondary | Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data. | Posted | Median | Full Range | hours (hr) | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
|
|
|
| Secondary | Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon | Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data. | Posted | Mean | Standard Deviation | hour*picogram per millilitre (hr*pg/mL) | Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration |
|
|
|
| 0 |
| 18 |
| 16 |
| 18 |
| EG001 | NG 1 mg | NG dose of 1 mg | 0 | 12 | 9 | 12 |
| EG002 | NG 2 mg | NG dose of 2 mg | 0 | 18 | 15 | 18 |
| EG003 | NG 3 mg | NG dose of 3 mg | 0 | 8 | 8 | 8 |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Pallor | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rhinorrhoea | 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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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Ear pruritus | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Ocular Hyperaemia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Catheter Site Bruise | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Catheter Site Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Hunger | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vessel Puncture Site Bruise | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Sinus Headache | Nervous system 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 Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal Pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Cold Sweat | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |