Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

NCTNCT03724981Other id17155Other idH9X-MC-B021

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 312 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 18 Oct 2018
Primary completion: 12 Apr 2019
Completion: 12 Apr 2019
First posted: 30 Oct 2018
Last update posted: 24 Apr 2020
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201820192020

Ph 4
A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
NCT03724981
18 Oct 2018 to 12 Apr 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Dulaglutide PenDrug
Semaglutide PenDrug

Arms2

Experimental
Dulaglutide Pen
Injection of commercial dulaglutide pen on a practice pad.
Experimental
Semaglutide Pen
Injection of commercial semaglutide pen on a practice pad.

Primary outcomes1

Outcomes the sponsor listed as primary.

Participant Preference Between 2 Injection Devices Based on Global Preference Item
Time frame · Day 1
Registry description
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.

Secondary outcomes(1)

Participant Preference Between 2 Injection Devices Based on Ease of Use
Time frame · Day 1
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1

Participant Preference Between 2 Injection Devices Based on Global Preference Item

Group	Value (percentage of participants)
Dulaglutide to Semaglutide	87.7
Semaglutide to Dulaglutide	80.6

Secondary and other outcome results(1)

Secondary outcomeNumber· Day 1

Participant Preference Between 2 Injection Devices Based on Ease of Use

Group	Value (percentage of participants)
Dulaglutide to Semaglutide	87.1
Semaglutide to Dulaglutide	86.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
DulaglutideInjection of commercial dulaglutide pen on a practice pad.	0 / 310	0 / 0	0 / 0
SemaglutideInjection of commercial semaglutide pen on a practice pad.	0 / 310	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

4 results

Assessing patient PREFERence between the dulaglutide pen and the semaglutide pen: A crossover study (PREFER).

Matza et al. 2020Diabetes, obesity & metabolismcited by 37

PMID 31646727PMC7064885DOI 10.1111/dom.13902PUB-31646727

Free to read · publisher termsCC BY-NC4 results

Read at source See results (4)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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