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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-B021 | Other Identifier | Eli Lilly and Company |
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In this study participants will try out two different types of drug injection pens (dulaglutide and semaglutide) on a practice pad and decide which device they prefer. No study drug will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulaglutide Pen | Experimental | Injection of commercial dulaglutide pen on a practice pad. |
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| Semaglutide Pen | Experimental | Injection of commercial semaglutide pen on a practice pad. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide Pen | Drug | Injected on a practice pad. |
| |
| Semaglutide Pen |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Preference Between 2 Injection Devices Based on Global Preference Item | Preference of injection device was assessed by questionnaire which asks, "Overall, which device do you prefer?" The Prescott test will be run to examine if a statistically significant difference in preference between the devices exits, while controlling for order effects and taking into account the neutral responses. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Preference Between 2 Injection Devices Based on Ease of Use | Participants responded to the Diabetes Injection Device - Preference Questionnaire (DID-PQ), Item 9 (ease of use) to compare the dulaglutide and semaglutide devices with regard to ease. Response options of "strongly prefer" and "prefer" were combined for each device, resulting in 3 categories: prefer dulaglutide, prefer semaglutide, and no preference. The Prescott test will be run to examine if a statistically significant difference in preference between the devices exists while, controlling for order effects. |
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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 |
|---|---|---|---|---|---|---|
| Valley Research | Fresno | California | 93720 | United States | ||
| Long Beach Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31646727 | Background | Matza LS, Boye KS, Stewart KD, Coyne KS, Wullenweber PK, Cutts KN, Jordan JB, Wang Q, Yu M, Currie BM, Malley KG, Ishak KJ, Hietpas RT, Garcia-Perez LE. Assessing patient PREFERence between the dulaglutide pen and the semaglutide pen: A crossover study (PREFER). Diabetes Obes Metab. 2020 Mar;22(3):355-364. doi: 10.1111/dom.13902. Epub 2019 Dec 19. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Injections with the 2 injection devices were performed on a practice pad.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dulaglutide to Semaglutide | Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad. |
| FG001 | Semaglutide to Dulaglutide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Device |
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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 | Nov 30, 2018 | Apr 9, 2020 |
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| Drug |
Injected on a practice pad. |
|
| Day 1 |
| Long Beach |
| California |
| 90807 |
| United States |
| Palm Harbor Medical Associates | Palm Harbor | Florida | 34684 | United States |
| Georgia Clinical Research | Snellville | Georgia | 30078 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| L-Marc Research Center | Louisville | Kentucky | 40213 | United States |
| Evidera | Bethesda | Maryland | 20814 | United States |
| Carolina Research Center, Inc. | Shelby | North Carolina | 28150 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| BRCR Medical Center, Inc. | Camp Hill | Pennsylvania | 17011 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Juno Research, LLC | Houston | Texas | 77054 | United States |
| PI-Coor Clinical Research, LLC | Annandale | Virginia | 22003 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
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| NOT COMPLETED |
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| Second Device |
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All Randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants were randomized to one of two treatment sequences: dulaglutide injection device to semaglutide injection device or semaglutide injection device to dulaglutide injection device. |
| 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 | Standard Deviation | 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 |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Participant Preference Between 2 Injection Devices Based on Global Preference Item | Preference of injection device was assessed by questionnaire which asks, "Overall, which device do you prefer?" The Prescott test will be run to examine if a statistically significant difference in preference between the devices exits, while controlling for order effects and taking into account the neutral responses. | All randomized participants with exposure to both devices and Global Preference data. | Posted | Number | percentage of participants | Day 1 |
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| Secondary | Participant Preference Between 2 Injection Devices Based on Ease of Use | Participants responded to the Diabetes Injection Device - Preference Questionnaire (DID-PQ), Item 9 (ease of use) to compare the dulaglutide and semaglutide devices with regard to ease. Response options of "strongly prefer" and "prefer" were combined for each device, resulting in 3 categories: prefer dulaglutide, prefer semaglutide, and no preference. The Prescott test will be run to examine if a statistically significant difference in preference between the devices exists while, controlling for order effects. | All randomized participants with exposure to both devices and Ease of Use data. | Posted | Number | percentage of participants | Day 1 |
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All cause mortality: All randomized participants with exposure to both devices. Safety: Zero participants analyzed. No safety data collected as injections were performed on a practice pad.
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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 | Injection of commercial dulaglutide pen on a practice pad. | 0 | 310 | 0 | 0 | 0 | 0 |
| EG001 | Semaglutide | Injection of commercial semaglutide pen on a practice pad. | 0 | 310 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2018 | Apr 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Semaglutide Device Preference |
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