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| ID | Type | Description | Link |
|---|---|---|---|
| I8Z-MC-APCA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.
This study will last at least 35 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3185643 | Experimental | LY3185643 administered subcutaneous (SC) |
|
| rGlucagon | Experimental | rGlucagon administered subcutaneous (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3185643 | Drug | Administered SC |
| |
| rGlucagon |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon | Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon. | 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon | Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon. | 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose |
| Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon | Cmax was assessed for LY3185643 and rGlucagon. | -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose |
| Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon | Cmax was assessed for C-peptide of LY3185643 and rGlucagon | -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose |
| Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon | Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon. | -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose |
| Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon |
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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. | Singapore | Singapore |
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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Crossover study with three periods. Each participant received up to 3 doses of study drug (rGlucagon and/or LY3185643) in a dosing day as per the dosing sequence in each period with 7 to 12 days washout period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (Sequence 1-9-7: 6-4-8: 5-3-2) | LY3185643 and rGlucagon were administered as single subcutaneous (SC) doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3. Dose assignment was: Dose 1 = 10 microgram (μg) LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG001 | Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 ) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG002 | Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG003 | Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG004 | Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG005 | Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG006 | Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG007 | Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| FG008 | Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) ) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||
| Period 2 |
| |||||||||||||||||||
| Period 3 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (Sequence 1,9,7: 6,4,8:5,3,2) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| 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 | Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon | Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon. | All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose |
|
Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
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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 | 10 ug LY3185643 | LY3185643 has been administered SC as single dose of 10 ug. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
Not provided
| 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 | Dec 8, 2016 | May 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2016 | May 20, 2019 | SAP_001.pdf |
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| Drug |
Administered SC |
|
Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon.
| -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose |
| Scheduling Conflicts |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 ) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG002 | Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG003 | Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG004 | Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG005 | Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG006 | Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG007 | Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG008 | Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) ) | LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3. Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon. |
| BG009 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
LY3185643 has been administered SC as single dose of 25 ug.
| OG002 | 50 ug LY3185643 | LY3185643 has been administered SC as single dose of 50 ug. |
| OG003 | 100 ug LY3185643 | LY3185643 has been administered SC as single dose of 100 ug. |
| OG004 | 200 ug LY3185643 | LY3185643 has been administered SC as single dose of 200 ug. |
| OG005 | 10 ug rGlucagon | rGlucagon has been administered SC as single dose of 10 ug. |
| OG006 | 25 ug rGlucagon | rGlucagon has been administered SC as single dose of 25 ug. |
| OG007 | 50 ug rGlucagon | rGlucagon has been administered SC as single dose of 50 ug. |
| OG008 | 200 ug rGlucagon | rGlucagon has been administered SC as single dose of 200 ug. |
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon | Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon. | All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per milliliter (pg*hr/mL) | 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose |
|
|
|
| Primary | Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon | Cmax was assessed for LY3185643 and rGlucagon. | All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose |
|
|
|
| Primary | Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon | Cmax was assessed for C-peptide of LY3185643 and rGlucagon | All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data. | Posted | Mean | Standard Deviation | picomole per liter (pmol/L) | -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose |
|
|
|
| Primary | Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon | Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon. | All randomized participants who received at least one dose of study drug (LY3185643, C-peptide) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data. | Posted | Mean | Standard Deviation | milligram*hour per deciliter (mg*hr/dL) | -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose |
|
|
|
| Primary | Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon | Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon. | All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data. | Posted | Mean | Standard Deviation | picomole*hour per liter (pmol*h/L) | -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose |
|
|
|
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | 25 ug LY3185643 | LY3185643 has been administered SC as single dose of 25 ug. | 0 | 23 | 0 | 23 | 3 | 23 |
| EG002 | 50 ug LY3185643 | LY3185643 has been administered SC as single dose of 50 ug. | 0 | 21 | 0 | 21 | 3 | 21 |
| EG003 | 100 ug LY3185643 | LY3185643 has been administered SC as single dose of 100 ug. | 0 | 22 | 0 | 22 | 5 | 22 |
| EG004 | 200 ug LY3185643 | LY3185643 has been administered SC as single dose of 200 ug. | 0 | 22 | 0 | 22 | 4 | 22 |
| EG005 | 10 ug rGlucagon | rGlucagon has been administered SC as single dose of 10 ug. | 0 | 21 | 0 | 21 | 2 | 21 |
| EG006 | 25 ug rGlucagon | rGlucagon has been administered SC as single dose of 25 ug. | 0 | 21 | 0 | 21 | 1 | 21 |
| EG007 | 50 ug rGlucagon | rGlucagon has been administered SC as single dose of 50 ug. | 0 | 22 | 0 | 22 | 2 | 22 |
| EG008 | 200 ug rGlucagon | rGlucagon has been administered SC as single dose of 200 ug. | 0 | 20 | 0 | 20 | 2 | 20 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Administration site bruise | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.