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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBH | Other Identifier | Eli Lilly and Company | |
| AMG110 | Other Identifier | AMG Medical Inc | |
| AMG-P4-459 | Other Identifier | AMG Medical Inc |
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Drug delivery was below target dose due to partial obstruction by aggregated particles.
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| Name | Class |
|---|---|
| Locemia Solutions ULC | INDUSTRY |
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This study will investigate how the body processes nasal glucagon and the effect of nasal glucagon on the body. After an 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, the study drug will be delivered into the participant's nostril(s) (intranasally) once or twice in each of four study periods. The study is open to adults with type 1 or type 2 diabetes and is expected to last about 50 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Treatment 1, single nasal glucagon (NG) dose of 3 milligram (mg). |
|
| Treatment 2 | Experimental | Treatment 2, NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later. |
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| Treatment 3 | Experimental | Treatment 3, NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later. |
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| Treatment 4 | Experimental | Treatment 4, NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug | Administered intranasally. |
|
| 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, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment | |
| PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 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, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 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, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment | |
| Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 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, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment | |
| PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
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Inclusion Criteria:
Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)
A female participant must meet one of the following criteria:
Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
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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4-period, 4 sequence, repeated single dose design with 7 days washout period between each dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (Treatment 1, 2, 3 and 4) | The intranasal (IN) glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence: Period 1: Single 3 mg dose of Nasal glucagon (NG). Period 2: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the same nostril (for a total of 6 mg of glucagon). Period 3: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon). Period 4: Single 3 mg dose of Nasal Glucagon at time 0, followed by a second 3 mg dose of Nasal Glucagon immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon). |
| FG001 | Sequence 2 (Treatment 2, 3, 4 and 1) | The Intranasal glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence: Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon). Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon). Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon). Period 4: Single 3 mg dose of NG. |
| FG002 | Sequence 3 (Treatment 3, 4, 1 and 2) | The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence: Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon). Period 2: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon). Period 3: Single 3 mg dose of NG. Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon). |
| FG003 | Sequence 4 (Treatment 4, 1, 2 and 3) | The IN glucagon formulation was randomly administered in the morning after a 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, as per below sequence: Period 1: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG immediately after (within 1 minute) in the opposite nostril (for a total of 6 mg of glucagon). Period 2: Single 3 mg dose of NG. Period 3: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the same nostril (for a total of 6 mg of glucagon). Period 4: Single 3 mg dose of NG at time 0, followed by a second 3 mg dose of NG 15 minutes later in the opposite nostril (for a total of 6 mg of glucagon). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | A minimum dose of 3 mg NG 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 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
|
First dose of study drug (Day 1) until study discontinuation (Day 10)
All enrolled participants.
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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 | Treatment 1 | Single NG dose of 3 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
The study drug was discovered to be delivering a potential sub-target dosing to some participants, due to partial obstruction of the delivery device by aggregation of particles. The study was terminated early with no safety concern for participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Canada |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later |
| OG003 | Treatment 4 | NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril. |
|
| Primary | PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
|
|
| Primary | PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
|
|
| Primary | PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
|
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| Primary | Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG) | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatment |
|
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| Primary | PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
|
|
| Primary | PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) | Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose. | Posted | Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
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|
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Treatment 2 | NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later. | 0 | 3 | 2 | 3 |
| EG002 | Treatment 3 | NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later. | 0 | 3 | 3 | 3 |
| EG003 | Treatment 4 | NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril. | 0 | 3 | 3 | 3 |
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Parosmia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |