Clinical trial NCT03724981: A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
Official title: Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Preference Between 2 Injection Devices Based on Global Preference Item
timeFrame: Day 1
Secondary outcomes:
measure: Participant Preference Between 2 Injection Devices Based on Ease of Use
timeFrame: Day 1
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Research
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: Palm Harbor
country: United States
facility: Palm Harbor Medical Associates
state: Florida
city: Snellville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Bethesda
country: United States
facility: Evidera
state: Maryland
city: Shelby
country: United States
facility: Carolina Research Center, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Camp Hill
country: United States
facility: BRCR Medical Center, Inc.
state: Pennsylvania
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Annandale
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.