A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
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| ClinicalTrials.gov Identifier: NCT03232983 |
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Recruitment Status :
Completed
First Posted : July 28, 2017
Results First Posted : April 30, 2020
Last Update Posted : April 30, 2020
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science |
| Condition |
Diabetes Mellitus, Type 2 |
| Interventions |
Drug: LY900014 (SC) Drug: LY900014 (IV) |
| Enrollment | 28 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | This is an open-label, randomized, crossover, up to 10-hour euglycemic clamp study in which participants were randomized into one of four treatment sequences. Participants received single doses of 15 units of LY900014 on 4 occasions (treatment Periods 1 through 4) with a wash-out period of at least 3 days between study drug administration. |
| Arm/Group Title | LY900014 Treatment Sequence 1: Abdomen,Thigh, Deltoid(Arm), IV | LY900014 Treatment Sequence 2: Deltoid, Abdomen, IV, Thigh | LY900014 Treatment Sequence 3: IV, Deltoid, Thigh, Abdomen | LY900014 Treatment Sequence 4: Thigh, IV, Abdomen, Deltoid |
|---|---|---|---|---|
 Arm/Group Description |
Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in Period 1, Thigh in Period 2, Deltoid (Arm) in Period 3, and single 15-U intravenous (IV) bolus injection in Period 4. | Single dose of 15-U of LY900014 administered SC into the: Deltoid in Period 1, Abdomen in Period 2, single 15-U IV bolus injection in Period 3, and single 15-U SC administration into the Thigh in Period 4. | Single 15-U IV bolus injection of LY900014 administered in Period 1, single 15-U dose administered SC in the Deltoid in Period 2, Thigh in Period 3, and Abdomen in Period 4. | Single dose of 15-U of LY900014 administered SC in Thigh in Period 1, single 15-U IV bolus injection in Period 2, single dose of 15-U administered SC in the Abdomen in Period 3, and Deltoid in Period 4. |
| Period Title: Period 1 | ||||
| Started | 7 | 7 | 7 | 7 |
| Received at Least One Dose of Study Drug | 7 | 7 | 7 | 7 |
| Completed | 7 | 7 | 6 | 7 |
| Not Completed | 0 | 0 | 1 | 0 |
| Reason Not Completed | ||||
| Physician Decision | 0 | 0 | 1 | 0 |
| Period Title: Washout Period 1 | ||||
| Started | 7 | 7 | 6 | 7 |
| Completed | 7 | 7 | 6 | 7 |
| Not Completed | 0 | 0 | 0 | 0 |
| Period Title: Period 2 | ||||
| Started | 7 | 7 | 6 | 7 |
| Completed | 7 | 7 | 6 | 7 |
| Not Completed | 0 | 0 | 0 | 0 |
| Period Title: Washout Period 2 | ||||
| Started | 7 | 7 | 6 | 7 |
| Completed | 7 | 7 | 5 | 6 |
| Not Completed | 0 | 0 | 1 | 1 |
| Reason Not Completed | ||||
| Physician Decision | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 0 | 0 | 0 | 1 |
| Period Title: Period 3 | ||||
| Started | 7 | 7 | 5 | 6 |
| Completed | 7 | 7 | 5 | 6 |
| Not Completed | 0 | 0 | 0 | 0 |
| Period Title: Washout Period 3 | ||||
| Started | 7 | 7 | 5 | 6 |
| Completed | 7 | 7 | 5 | 6 |
| Not Completed | 0 | 0 | 0 | 0 |
| Period Title: Period 4 | ||||
| Started | 7 | 7 | 5 | 6 |
| Completed | 6 | 7 | 5 | 6 |
| Not Completed | 1 | 0 | 0 | 0 |
| Reason Not Completed | ||||
| Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Overall | |
|---|---|---|
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Arm/Group Description |
Single 15-U dose of LY900014 administered in treatment Period 1- 4, as SC injection into the abdomen, the thigh, the deltoid or an IV bolus injection, per randomized treatment sequence. | |
| Overall Number of Baseline Participants | 28 | |
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Baseline Analysis Population Description |
All participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 28 participants | |
| 39.8 (8.6) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 28 participants | |
| Female | 0 | |
| Male | 28 | |
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 28 participants | |
| Hispanic or Latino | 0 | |
| Not Hispanic or Latino | 28 | |
| Unknown or Not Reported | 0 | |
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 28 participants | |
| American Indian or Alaska Native | 0 | |
| Asian | 28 | |
| Native Hawaiian or Other Pacific Islander | 0 | |
| Black or African American | 0 | |
| White | 0 | |
| More than one race | 0 | |
| Unknown or Not Reported | 0 | |
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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| Singapore | Number Analyzed | 28 participants |
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28 100.0%
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Weight
Geometric Mean (Standard Deviation) Unit of measure: Kilograms (kg) |
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| Number Analyzed | 28 participants | |
| 70.11 (10.48) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Chief Medical Officer |
| Organization: | Eli Lilly and Company |
| Phone: | 800-545-5979 |
| EMail: | Clinicaltrials.gov@lilly.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT03232983 |
| Other Study ID Numbers: |
16639 I8B-MC-ITRT ( Other Identifier: Eli Lilly and Company ) |
| First Submitted: | July 26, 2017 |
| First Posted: | July 28, 2017 |
| Results First Submitted: | April 20, 2020 |
| Results First Posted: | April 30, 2020 |
| Last Update Posted: | April 30, 2020 |