A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

Study Overview
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Brief Summary
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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.

Official Title
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Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Dulaglutide Pen
* Drug: Semaglutide Pen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dulaglutide Pen<br>Injection of commercial dulaglutide pen on a practice pad. | Drug: Dulaglutide Pen<br>* Injected on a practice pad.<br>|
| Experimental: Semaglutide Pen<br>Injection of commercial semaglutide pen on a practice pad. | Drug: Semaglutide Pen<br>* Injected on a practice pad.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Day 1 |