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A Study Comparing the Dulaglutide Pen and the Semaglutide Pen
Plain-language guide to NCT03724981: phase 4 randomized trial of Semaglutide and Dulaglutide, 312 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03724981
- Phase
- phase 4
- Status
- completed
- Start
- 2018-10-18
- Completion (planned or actual)
- 2019-04-12
- Participants
- 312 (actual)
- Design
- randomized, open label (everyone knows who gets what), other
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Semaglutide and Dulaglutide.
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.
It had two arms (groups): Dulaglutide Pen (experimental) and Semaglutide Pen (experimental).
Injection of commercial dulaglutide pen on a practice pad.
Injection of commercial semaglutide pen on a practice pad.
The registry classes the interventions as drug.
Who Took Part
312 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: currently diagnosed with gestational diabetes and/or type 1 diabetes; is a health care practitioner who is trained in giving injections.
How the Study Was Run
Design: randomized, crossover and open-label.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2018-10-18 with completion listed for 2019-04-12.
It ran at 14 sites in United States (14).
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Participant Preference Between 2 Injection Devices Based on Global Preference Item (time frame: Day 1).
It also tracked 1 secondary outcome, for example Participant Preference Between 2 Injection Devices Based on Ease of Use.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Semaglutide and Dulaglutide in 312 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Semaglutide compound page and the Dulaglutide compound page, all human trials.
Our Notes on the Compounds
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.