A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

NCT ID: NCT03724981

Last Updated: 2020-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2019-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dulaglutide Pen

Injection of commercial dulaglutide pen on a practice pad.

Group Type EXPERIMENTAL

Dulaglutide Pen

Intervention Type DRUG

Injected on a practice pad.

Semaglutide Pen

Injection of commercial semaglutide pen on a practice pad.

Group Type EXPERIMENTAL

Semaglutide Pen

Intervention Type DRUG

Injected on a practice pad.

Interventions

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Dulaglutide Pen

Injected on a practice pad.

Intervention Type DRUG

Semaglutide Pen

Injected on a practice pad.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Valley Research

Fresno, California, United States

Site Status

Long Beach Center for Clinical Research

Long Beach, California, United States

Site Status

Palm Harbor Medical Associates

Palm Harbor, Florida, United States

Site Status

Georgia Clinical Research

Snellville, Georgia, United States

Site Status

Cedar-Crosse Research Center

Chicago, Illinois, United States

Site Status

L-Marc Research Center

Louisville, Kentucky, United States

Site Status

Evidera

Bethesda, Maryland, United States

Site Status

Carolina Research Center, Inc.

Shelby, North Carolina, United States

Site Status

Lillestol Research LLC

Fargo, North Dakota, United States

Site Status

BRCR Medical Center, Inc.

Camp Hill, Pennsylvania, United States

Site Status

Juno Research

Houston, Texas, United States

Site Status

Juno Research, LLC

Houston, Texas, United States

Site Status

PI-Coor Clinical Research, LLC

Annandale, Virginia, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31646727 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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H9X-MC-B021

Identifier Type: OTHER

Identifier Source: secondary_id

17155

Identifier Type: -

Identifier Source: org_study_id

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