A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Dulaglutide Pen; Drug: Semaglutide Pen

• Registration Number: NCT03724981
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study Start: 2018-10-18
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Primary Completion: 2019-04-12
• Study Completion: 2019-04-12
• Status Verified: 2019-08
• Results First Submitted: 2020-04-10
• Results First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dulaglutide Pen	Dulaglutide Pen	Injection of commercial dulaglutide pen on a practice pad.
Semaglutide Pen	Semaglutide Pen	Injection of commercial semaglutide pen on a practice pad.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (14)

Long Beach Center for Clinical Research; 🇺🇸 Long Beach, California, United States

Palm Harbor Medical Associates; 🇺🇸 Palm Harbor, Florida, United States

Georgia Clinical Research; 🇺🇸 Snellville, Georgia, United States

L-Marc Research Center; 🇺🇸 Louisville, Kentucky, United States

Evidera; 🇺🇸 Bethesda, Maryland, United States

Carolina Research Center, Inc.; 🇺🇸 Shelby, North Carolina, United States

Lillestol Research LLC; 🇺🇸 Fargo, North Dakota, United States

BRCR Medical Center, Inc.; 🇺🇸 Camp Hill, Pennsylvania, United States

PI-Coor Clinical Research, LLC; 🇺🇸 Annandale, Virginia, United States

Manassas Clinical Research Center; 🇺🇸 Manassas, Virginia, United States

Valley Research; 🇺🇸 Fresno, California, United States

Cedar-Crosse Research Center; 🇺🇸 Chicago, Illinois, United States

Juno Research; 🇺🇸 Houston, Texas, United States

Juno Research, LLC; 🇺🇸 Houston, Texas, United States