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NCT Number: NCT03724981

A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Valley Research, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide Pen

Drug

Injected on a practice pad.

Semaglutide Pen

Drug

Injected on a practice pad.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2018
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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