A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724981
• Other study ID #: 17155
• Secondary ID: H9X-MC-B021
• Status: Completed
• Phase: Phase 4
• Start date: October 18, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: August 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dulaglutide Pen
Injected on a practice pad.
• Semaglutide Pen
Injected on a practice pad.

Locations

Country	Name	City	State
United States	PI-Coor Clinical Research, LLC	Annandale	Virginia
United States	Evidera	Bethesda	Maryland
United States	BRCR Medical Center, Inc.	Camp Hill	Pennsylvania
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Valley Research	Fresno	California
United States	Juno Research	Houston	Texas
United States	Juno Research, LLC	Houston	Texas
United States	Long Beach Center for Clinical Research	Long Beach	California
United States	L-Marc Research Center	Louisville	Kentucky
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Palm Harbor Medical Associates	Palm Harbor	Florida
United States	Carolina Research Center, Inc.	Shelby	North Carolina
United States	Georgia Clinical Research	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, García-Pérez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1
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.	Day 1