A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
2 other identifiers
interventional
312
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Oct 2018
Shorter than P25 for phase_4 diabetes-mellitus-type-2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2018
CompletedStudy Start
First participant enrolled
October 18, 2018
CompletedFirst Posted
Study publicly available on registry
October 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2019
CompletedResults Posted
Study results publicly available
April 24, 2020
CompletedApril 24, 2020
August 1, 2019
6 months
October 12, 2018
April 10, 2020
April 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Participant Preference Between 2 Injection Devices Based on Ease of Use
Day 1
Study Arms (2)
Dulaglutide Pen
EXPERIMENTALInjection of commercial dulaglutide pen on a practice pad.
Semaglutide Pen
EXPERIMENTALInjection of commercial semaglutide pen on a practice pad.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Valley Research
Fresno, California, 93720, United States
Long Beach Center for Clinical Research
Long Beach, California, 90807, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684, United States
Georgia Clinical Research
Snellville, Georgia, 30078, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
Evidera
Bethesda, Maryland, 20814, United States
Carolina Research Center, Inc.
Shelby, North Carolina, 28150, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
BRCR Medical Center, Inc.
Camp Hill, Pennsylvania, 17011, United States
Juno Research
Houston, Texas, 77040, United States
Juno Research, LLC
Houston, Texas, 77054, United States
PI-Coor Clinical Research, LLC
Annandale, Virginia, 22003, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Related 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, 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.
PMID: 31646727BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2018
First Posted
October 30, 2018
Study Start
October 18, 2018
Primary Completion
April 12, 2019
Study Completion
April 12, 2019
Last Updated
April 24, 2020
Results First Posted
April 24, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.