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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBD | Other Identifier | Eli Lilly and Company | |
| AMG 101 | Other Identifier | AMG Medical Inc. | |
| GUO-P1-557 | Other Identifier | AMG Medical Inc. |
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| Name | Class |
|---|---|
| Locemia Solutions ULC | INDUSTRY |
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The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. The study lasted about 23 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Glucagon (NG) - 0.5 mg | Experimental | Ng dose at 0.5 milligram (mg) administered once in one of four study periods. |
|
| NG - 1.0 mg | Experimental | Ng dose at 1.0 milligram (mg) administered once in one of four study periods. |
|
| NG - 2.0 mg | Experimental | Ng dose at 2.0 milligram (mg) administered once in one of four study periods. |
|
| SC Glucagon 1 mg | Active Comparator | Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug | Administered intranasally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) | Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline through Study Completion (Day 23) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment | |
| PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon |
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mount Royal | Quebec | H3P 3P1 |
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This was a four-period crossover study in which participants received a single dose of study drug in each period, with seven days between each dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (T1/T2/T3/T4) | Treatment (T1) = nasal glucagon (NG) dose of 0.5 milligram (mg), T2 = NG dose of 1 mg, T3 = NG dose of 2 mg, T4 = subcutaneous (SC) glucagon dose of 1 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered. |
| FG001 | Sequence 2 (T2/T3/T4/T1) | T2 = NG dose of 1 mg, T3 = NG dose of 2 mg, T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered. |
| FG002 | Sequence 3 (T3/T4/T1/T2) | T3 = NG dose of 2 mg, T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg, T2 = NG dose of 1 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered. |
| FG003 | Sequence 4 (T4/T1/T2/T3) | T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg, T2 = NG dose of 1 mg, T3 = NG dose of 2 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period One |
| ||||||||||||||||
| Study Period Two |
| ||||||||||||||||
| Study Period Three |
| ||||||||||||||||
| Study Period Four |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | In each of four study periods, a single dose of either NG or SC glucagon was administered. |
| 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 With One or More Serious Adverse Event(s) (SAEs) | Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who entered study period four. | Posted | Count of Participants | Participants | No | Baseline through Study Completion (Day 23) |
|
First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
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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 | NG 0.5 mg | NG dose of 0.5 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 18.0 | Non-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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| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Glucagon | Drug | Administered SC. |
|
| Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
| PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
| PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
| Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
| PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
| PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
| Canada |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
NG dose of 1 mg. |
| OG002 | NG 2 mg | NG dose of 2 mg. |
| OG003 | SC Glucagon 1 mg | Subcutaneous (SC) glucagon dose of 1 mg. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon | All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 picogram per milliliter [pg/mL]) except for one participant at one time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per milliliter (pg*h/mL) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| Secondary | PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon | All randomized participants with evaluable PK data. AUC(0-inf) could not be calculated for the NG 0.5 mg arm, because all participants had serum glucagon levels below the lower limit of quantification (100 pg/mL) except for one participant at one time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| Secondary | PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 pg/mL) except for one participant at one time point. | Posted | Median | Full Range | hour (h) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| Secondary | PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 pg/mL) except for one participant at one time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| Secondary | Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose | All randomized participants with evaluable PD data. | Posted | Mean | Standard Error | millimole*hour per liter (mmol*h/L) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| Secondary | PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | All randomized participants with evaluable PD data. | Posted | Median | Full Range | hour (h) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| Secondary | PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) | All randomized participants with evaluable PD data. | Posted | Mean | Standard Error | millimole per liter (mmol/L) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | NG 1 mg | NG dose of 1 mg. | 0 | 14 | 6 | 14 |
| EG002 | NG 2 mg | NG dose of 2 mg. | 0 | 16 | 8 | 16 |
| EG003 | SC Glucagon 1 mg | SC glucagon dose of 1 mg. | 0 | 15 | 6 | 15 |
| Eye pruritus | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Vessel puncture site haematoma | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Vessel puncture site reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |