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A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dulaglutide Pen
Semaglutide Pen
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valley Research
  • Long Beach Center for Clinical Research
  • Palm Harbor Medical Associates
  • Georgia Clinical Research
  • Cedar-Crosse Research Center
  • L-Marc Research Center
  • Evidera
  • Carolina Research Center, Inc.
  • Lillestol Research LLC
  • BRCR Medical Center, Inc.
  • Juno Research
  • Juno Research, LLC
  • PI-Coor Clinical Research, LLC
  • Manassas Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dulaglutide Pen

Semaglutide Pen

Arm Description

Injection of commercial dulaglutide pen on a practice pad.

Injection of commercial semaglutide pen on a practice pad.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 12, 2018
Last Updated
April 10, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03724981
Brief Title
A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
Official Title
Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
April 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dulaglutide Pen
Arm Type
Experimental
Arm Description
Injection of commercial dulaglutide pen on a practice pad.
Arm Title
Semaglutide Pen
Arm Type
Experimental
Arm Description
Injection of commercial semaglutide pen on a practice pad.
Intervention Type
Drug
Intervention Name(s)
Dulaglutide Pen
Intervention Description
Injected on a practice pad.
Intervention Type
Drug
Intervention Name(s)
Semaglutide Pen
Intervention Description
Injected on a practice pad.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Long Beach Center for Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Palm Harbor Medical Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Georgia Clinical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
L-Marc Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Evidera
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Carolina Research Center, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
BRCR Medical Center, Inc.
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
PI-Coor Clinical Research, LLC
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Citations:
PubMed Identifier
31646727
Citation
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.
Results Reference
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A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

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