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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBDT | Other Identifier | Eli Lilly and Company |
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The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled manual syringe, the other given by an auto-injector. Injections will be separated by a minimum 28-day washout period. The study will evaluate if the levels of drug in the blood are similar when given by each method. Participation in the study is likely to take approximately 7 weeks, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual syringe | Active Comparator | Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28-day minimum washout period. |
|
| Auto-injector | Experimental | Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28-day washout period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Biological | Administered by subcutaneous (SC) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide | Predose to 336 hours postdose | |
| Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide | Predose to 336 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide | Predose to 336 hours postdose |
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Inclusion Criteria:
Are overtly healthy males or females, as determined by medical history and physical examination
Male participants with female partners of child-bearing potential or partners who are pregnant or breastfeeding agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator
The method may be one of the following:
Female participants not of child-bearing potential (that is, are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrollment
Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or spontaneous amenorrhea for 6 to 12 months, with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliters (mIU/mL)
Female participants who have undergone sterilization by tubal ligation agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrollment
Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meters squared (kg/m^2), inclusive, at screening
Have clinical laboratory test results within the normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling as per the protocol
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
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. | Daytona Beach | Florida | 32117 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Syringe First, Then Auto-injector | First Intervention: Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe. There was a washout period of at least 28 days between treatment periods. Second intervention: Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector. |
| FG001 | Auto-injector First, Then Manual Syringe | First Intervention: Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector. There was a washout period of at least 28 days between treatment periods. Second intervention: Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Period of at Least 28 Days |
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| Second Intervention |
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Participants who received at least 1 dose of dulaglutide.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector. |
| Units | Counts |
|---|---|
| Participants |
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| 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: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide | Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms times hours per milliliters | Predose to 336 hours postdose |
|
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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 | Auto-injector | Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | 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 |
|---|---|
| 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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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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| United States |
| Protocol Violation |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide | Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose to 336 hours postdose |
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|
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| Secondary | Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide | Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data. | Posted | Median | Full Range | hours | Predose to 336 hours postdose |
|
|
|
| 0 |
| 47 |
| 18 |
| 47 |
| EG001 | Manual Syringe | Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period. | 0 | 49 | 18 | 49 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| D004700 | Endocrine System Diseases |