Trial Outcomes & Findings for A Study Comparing the Dulaglutide Pen and the Semaglutide Pen (NCT NCT03724981)

Last Updated: 2020-04-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

312 participants

Primary outcome timeframe

Day 1

Results posted on

2020-04-24

Participant Flow

Injections with the 2 injection devices were performed on a practice pad.

Participant milestones

Participant milestones
Measure	Dulaglutide to Semaglutide Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad.	Semaglutide to Dulaglutide Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
First Device STARTED	156	156
First Device COMPLETED	155	155
First Device NOT COMPLETED	1	1
Second Device STARTED	155	155
Second Device COMPLETED	155	155
Second Device NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dulaglutide to Semaglutide Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad.	Semaglutide to Dulaglutide Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad.
First Device Protocol Violation	1	1

Baseline Characteristics

A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=310 Participants Participants were randomized to one of two treatment sequences: dulaglutide injection device to semaglutide injection device or semaglutide injection device to dulaglutide injection device.
Age, Continuous	60.0 years STANDARD_DEVIATION 10.86 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	104 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	105 Participants n=5 Participants
Race (NIH/OMB) White	155 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants
Region of Enrollment United States	310 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Dulaglutide to Semaglutide n=155 Participants Injection of commercial dulaglutide pen on a practice pad, then injection of semaglutide on a practice pad.	Semaglutide to Dulaglutide n=155 Participants Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide on a practice pad.
Participant Preference Between 2 Injection Devices Based on Global Preference Item Dulaglutide Device Preference	87.7 percentage of participants	80.6 percentage of participants
Participant Preference Between 2 Injection Devices Based on Global Preference Item No Device Preference	2.6 percentage of participants	4.5 percentage of participants
Participant Preference Between 2 Injection Devices Based on Global Preference Item Semaglutide Device Preference	9.7 percentage of participants	14.8 percentage of participants

SECONDARY outcome

Timeframe: Day 1

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

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.

Outcome measures

Outcome measures
Measure	Dulaglutide to Semaglutide n=155 Participants Injection of commercial dulaglutide pen on a practice pad, then injection of semaglutide on a practice pad.	Semaglutide to Dulaglutide n=155 Participants Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide on a practice pad.
Participant Preference Between 2 Injection Devices Based on Ease of Use Dulaglutide Device Preference	87.1 percentage of participants	86.5 percentage of participants
Participant Preference Between 2 Injection Devices Based on Ease of Use No Device Preference	5.2 percentage of participants	7.7 percentage of participants
Participant Preference Between 2 Injection Devices Based on Ease of Use Semaglutide Device Preference	7.7 percentage of participants	5.8 percentage of participants

Adverse Events

Dulaglutide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Semaglutide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60