A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03724981
• Collaborator: (none)
• Enrollment: 312
• Locations: 14
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site: 22.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Dulaglutide Pen; Drug: Semaglutide Pen	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
• Actual Study Start Date: Oct 18, 2018
• Actual Primary Completion Date: Apr 12, 2019
• Actual Study Completion Date: Apr 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dulaglutide Pen Injection of commercial dulaglutide pen on a practice pad.	Drug: Dulaglutide Pen; Injected on a practice pad.
Experimental: Semaglutide Pen Injection of commercial semaglutide pen on a practice pad.	Drug: Semaglutide Pen; Injected on a practice pad.

Outcome Measures

Primary Outcome Measures

1. Participant Preference Between 2 Injection Devices Based on Global Preference Item [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.

Secondary Outcome Measures

1. Participant Preference Between 2 Injection Devices Based on Ease of Use [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Research	Fresno	California	United States	93720
2	Long Beach Center for Clinical Research	Long Beach	California	United States	90807
3	Palm Harbor Medical Associates	Palm Harbor	Florida	United States	34684
4	Georgia Clinical Research	Snellville	Georgia	United States	30078
5	Cedar-Crosse Research Center	Chicago	Illinois	United States	60607
6	L-Marc Research Center	Louisville	Kentucky	United States	40213
7	Evidera	Bethesda	Maryland	United States	20814
8	Carolina Research Center, Inc.	Shelby	North Carolina	United States	28150
9	Lillestol Research LLC	Fargo	North Dakota	United States	58104
10	BRCR Medical Center, Inc.	Camp Hill	Pennsylvania	United States	17011
11	Juno Research	Houston	Texas	United States	77040
12	Juno Research, LLC	Houston	Texas	United States	77054
13	PI-Coor Clinical Research, LLC	Annandale	Virginia	United States	22003
14	Manassas Clinical Research Center	Manassas	Virginia	United States	20110

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• 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

Study Documents (Full-Text)

• Study Protocol - Nov 30, 2018
• Statistical Analysis Plan - Oct 9, 2018

More Information

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, García-Pérez 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.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03724981
• Other Study ID Numbers: 17155; H9X-MC-B021
• First Posted: Oct 30, 2018
• Last Update Posted: Apr 24, 2020
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Dulaglutide

Study Results

Participant Flow

Pre-assignment Detail	Injections with the 2 injection devices were performed on a practice pad.

Arm/Group Title	Dulaglutide to Semaglutide	Semaglutide to Dulaglutide
Arm/Group Description	Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad.	Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
Period Title: First Device
STARTED	156	156
COMPLETED	155	155
NOT COMPLETED	1	1
Period Title: First Device
STARTED	155	155
COMPLETED	155	155
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Participants were randomized to one of two treatment sequences: dulaglutide injection device to semaglutide injection device or semaglutide injection device to dulaglutide injection device.
Overall Participants	310
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.0 (10.86)
Sex: Female, Male (Count of Participants)
Female	150 48.4%
Male	160 51.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	39 12.6%
Not Hispanic or Latino	167 53.9%
Unknown or Not Reported	104 33.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1%
Asian	10 3.2%
Native Hawaiian or Other Pacific Islander	1 0.3%
Black or African American	105 33.9%
White	155 50%
More than one race	8 2.6%
Unknown or Not Reported	28 9%
Region of Enrollment (Count of Participants)
United States	310 100%

Outcome Measures

1. Primary Outcome

Title	Participant Preference Between 2 Injection Devices Based on Global Preference Item
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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All randomized participants with exposure to both devices and Global Preference data.

Arm/Group Title	Dulaglutide to Semaglutide	Semaglutide to Dulaglutide
Arm/Group Description	Injection of commercial dulaglutide pen on a practice pad, then injection of semaglutide on a practice pad.	Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide on a practice pad.
Measure Participants	155	155
Dulaglutide Device Preference	87.7 28.3%	80.6 NaN
No Device Preference	2.6 0.8%	4.5 NaN
Semaglutide Device Preference	9.7 3.1%	14.8 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dulaglutide to Semaglutide, Semaglutide to Dulaglutide
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Prescott test
	Comments

2. Secondary Outcome

Title	Participant Preference Between 2 Injection Devices Based on Ease of Use
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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All randomized participants with exposure to both devices and Ease of Use data.

Arm/Group Title	Dulaglutide to Semaglutide	Semaglutide to Dulaglutide
Arm/Group Description	Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad.	Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
Measure Participants	155	155
Dulaglutide Device Preference	87.1 28.1%	86.5 NaN
No Device Preference	5.2 1.7%	7.7 NaN
Semaglutide Device Preference	7.7 2.5%	5.8 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dulaglutide to Semaglutide, Semaglutide to Dulaglutide
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Prescott test
	Comments

Adverse Events

Adverse Event Reporting Description	All cause mortality: All randomized participants with exposure to both devices. Safety: Zero participants analyzed. No safety data collected as injections were performed on a practice pad.
Arm/Group Title	Dulaglutide		Semaglutide
Arm/Group Description	Injection of commercial dulaglutide pen on a practice pad.		Injection of commercial semaglutide pen on a practice pad.
All Cause Mortality
	Dulaglutide		Semaglutide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/310 (0%)		0/310 (0%)
Serious Adverse Events
	Dulaglutide		Semaglutide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Dulaglutide		Semaglutide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.