Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGDulaglutide Pen
Injected on a practice pad.
DRUGSemaglutide Pen
Injected on a practice pad.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes * Self-injection naïve to all injectable treatment (for example, diabetes therapies and other medical conditions) * Injection naïve to performing all injectable treatment (for example, diabetes therapies and other medical conditions) to others
Exclusion criteria
* Currently diagnosed with gestational diabetes and/or type 1 diabetes * Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator * Is a health care practitioner who is trained in giving injections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Preference Between 2 Injection Devices Based on Global Preference Item | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Preference Between 2 Injection Devices Based on Ease of Use | Day 1 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Injections with the 2 injection devices were performed on a practice pad.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 310 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Device | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 10.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 167 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 104 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Race (NIH/OMB) White | 155 Participants |
| Region of Enrollment United States | 310 Participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 310 | 0 / 310 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Day 1
Population: All randomized participants with exposure to both devices and Global Preference data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dulaglutide to Semaglutide | Participant Preference Between 2 Injection Devices Based on Global Preference Item | Dulaglutide Device Preference | 87.7 percentage of participants |
| Dulaglutide to Semaglutide | Participant Preference Between 2 Injection Devices Based on Global Preference Item | No Device Preference | 2.6 percentage of participants |
| Dulaglutide to Semaglutide | Participant Preference Between 2 Injection Devices Based on Global Preference Item | Semaglutide Device Preference | 9.7 percentage of participants |
| Semaglutide to Dulaglutide | Participant Preference Between 2 Injection Devices Based on Global Preference Item | Semaglutide Device Preference | 14.8 percentage of participants |
| Semaglutide to Dulaglutide | Participant Preference Between 2 Injection Devices Based on Global Preference Item | Dulaglutide Device Preference | 80.6 percentage of participants |
| Semaglutide to Dulaglutide | Participant Preference Between 2 Injection Devices Based on Global Preference Item | No Device Preference | 4.5 percentage of participants |
p-value: <0.0001Prescott test
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.
Time frame: Day 1
Population: All randomized participants with exposure to both devices and Ease of Use data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dulaglutide to Semaglutide | Participant Preference Between 2 Injection Devices Based on Ease of Use | Dulaglutide Device Preference | 87.1 percentage of participants |
| Dulaglutide to Semaglutide | Participant Preference Between 2 Injection Devices Based on Ease of Use | No Device Preference | 5.2 percentage of participants |
| Dulaglutide to Semaglutide | Participant Preference Between 2 Injection Devices Based on Ease of Use | Semaglutide Device Preference | 7.7 percentage of participants |
| Semaglutide to Dulaglutide | Participant Preference Between 2 Injection Devices Based on Ease of Use | Dulaglutide Device Preference | 86.5 percentage of participants |
| Semaglutide to Dulaglutide | Participant Preference Between 2 Injection Devices Based on Ease of Use | No Device Preference | 7.7 percentage of participants |
| Semaglutide to Dulaglutide | Participant Preference Between 2 Injection Devices Based on Ease of Use | Semaglutide Device Preference | 5.8 percentage of participants |
p-value: <0.0001Prescott test