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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBGM | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate a new formulation of dulaglutide (study drug) administered under the skin as one injection using a single dose pen compared to three injections using a pre filled syringe.
This study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
The study will last about 84 days, including screening and will require overnight stays in the clinical research unit (CRU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulaglutide (Reference) | Experimental | Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods |
|
| Dulaglutide (Test) | Experimental | Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide (Reference) | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide | Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC[0-∞]) of Dulaglutide. | Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28 |
| PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide | Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide. | Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28 |
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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 |
|---|---|---|---|---|---|---|
| Covance Dallas | Dallas | Texas | 75247 | United States |
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Participants were randomly assigned into different treatment sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2. Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A Dulaglutide (Reference) Then Dulaglutide (Test) | Dulaglutide (4.5 milligram [mg]) administered subcutaneously (SC) in 3 prefilled syringes (PFS) in period 1 and then dulaglutide 4.5 mg administered SC in single dose pen (SDP) in period 2. |
| FG001 | Sequence B Dulaglutide (Test) Then Dulaglutide (Reference) | Dulaglutide 4.5 mg administered SC in one (SDP) in period 1 and then Dulaglutide 4.5 mg administered SC (PFS) in period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Reference or Test) |
|
| |||||||||||||||||||||
| Period 2 (Test or Reference) |
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Dulaglutide Test and Reference | Dulaglutide 4.5 mg administered SC in 3 prefilled syringes and 1 single dose pen in one of two study periods. |
| 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 Zero to Infinity (AUC[0-∞]) of Dulaglutide | Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC[0-∞]) of Dulaglutide. | All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram.hour/milliliter (ng.h/mL) | Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28 |
|
Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
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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 | Dulaglutide (Reference) | Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | 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 | 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2017 | Jul 25, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 24, 2017 | Jul 25, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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| Dulaglutide (Test) | Drug | Administered SC |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 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 |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Dulaglutide (Test) |
Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods |
|
|
|
| Primary | PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide | Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide. | All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28 |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 15 |
| 24 |
| EG001 | Dulaglutide (Test) | Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods | 0 | 23 | 0 | 23 | 14 | 23 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
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