- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724981
A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
April 10, 2020 updated by: Eli Lilly and Company
Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
312
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Fresno, California, United States, 93720
- Valley Research
-
Long Beach, California, United States, 90807
- Long Beach Center For Clinical Research
-
-
Florida
-
Palm Harbor, Florida, United States, 34684
- Palm Harbor Medical Associates
-
-
Georgia
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Snellville, Georgia, United States, 30078
- Georgia Clinical Research
-
-
Illinois
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Chicago, Illinois, United States, 60607
- Cedar-Crosse Research Center
-
-
Kentucky
-
Louisville, Kentucky, United States, 40213
- L-MARC Research Center
-
-
Maryland
-
Bethesda, Maryland, United States, 20814
- Evidera
-
-
North Carolina
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Shelby, North Carolina, United States, 28150
- Carolina Research Center, Inc.
-
-
North Dakota
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Fargo, North Dakota, United States, 58104
- Lillestol Research LLC
-
-
Pennsylvania
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Camp Hill, Pennsylvania, United States, 17011
- BRCR Medical Center, Inc.
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Texas
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Houston, Texas, United States, 77040
- Juno Research
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Houston, Texas, United States, 77054
- Juno Research, LLC
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Virginia
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Annandale, Virginia, United States, 22003
- PI-Coor Clinical Research, LLC
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Manassas, Virginia, United States, 20110
- Manassas Clinical Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dulaglutide Pen
Injection of commercial dulaglutide pen on a practice pad.
|
Injected on a practice pad.
|
EXPERIMENTAL: Semaglutide Pen
Injection of commercial semaglutide pen on a practice pad.
|
Injected on a practice pad.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Preference Between 2 Injection Devices Based on Global Preference Item
Time Frame: 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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Preference Between 2 Injection Devices Based on Ease of Use
Time Frame: 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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 18, 2018
Primary Completion (ACTUAL)
April 12, 2019
Study Completion (ACTUAL)
April 12, 2019
Study Registration Dates
First Submitted
October 12, 2018
First Submitted That Met QC Criteria
October 29, 2018
First Posted (ACTUAL)
October 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17155
- H9X-MC-B021 (OTHER: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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