Diabetes Mellitus, Type 2Phase 4NCT03724981
A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
A Phase 4 study testing Dulaglutide Pen and Semaglutide Pen in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dulaglutide Pen and Semaglutide Pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Oct 2018to 12 Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
PI-Coor Clinical Research, LLC
Annandale, Virginia, 22003
Evidera
Bethesda, Maryland, 20814
BRCR Medical Center, Inc.
Camp Hill, Pennsylvania, 17011
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Lillestol Research LLC
Fargo, North Dakota, 58104
Valley Research
Fresno, California, 93720
Juno Research
Houston, Texas, 77040
Juno Research, LLC
Houston, Texas, 77054
Long Beach Center for Clinical Research
Long Beach, California, 90807
L-Marc Research Center
Louisville, Kentucky, 40213
Manassas Clinical Research Center
Manassas, Virginia, 20110
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684
Carolina Research Center, Inc.
Shelby, North Carolina, 28150
Georgia Clinical Research
Snellville, Georgia, 30078
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dulaglutide Pen, Semaglutide Pen
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulaglutide PenDrug
Injected on a practice pad.
Semaglutide PenDrug
Injected on a practice pad.
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide Pen | Experimental | Injection of commercial dulaglutide pen on a practice pad. Receives: Drug: Dulaglutide Pen |
| Semaglutide Pen | Experimental | Injection of commercial semaglutide pen on a practice pad. Receives: Drug: Semaglutide Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start18 Oct 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724981
- Sponsor's protocol ID
- 17155
- Other IDs
- H9X-MC-B021
- Status last verified
- Aug 2019
- First submitted
- 12 Oct 2018
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31646727
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
- ClinicalTrials.gov ID
- NCT03724981
- Acronym / sponsor ID
- 17155
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide Pen | Experimental | Drug: Dulaglutide PenInjection of commercial dulaglutide pen on a practice pad. |
| Semaglutide Pen | Experimental | Drug: Semaglutide PenInjection of commercial semaglutide pen on a practice pad. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dulaglutide PenInjected on a practice pad. | Drug | Dulaglutide Pen |
| Semaglutide PenInjected on a practice pad. | Drug | Semaglutide Pen |
Primary outcome
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.
1 secondary outcome
Participant Preference Between 2 Injection Devices Based on Ease of Use
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31646727Matza 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dulaglutide Pen and Semaglutide Pen in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Preference Between 2 Injection Devices Based on Global Preference Item (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.