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A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe
Plain-language guide to NCT01524770: phase 1 randomized trial of Dulaglutide, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01524770
- Phase
- phase 1
- Status
- completed
- Start
- 2012-03
- Completion (planned or actual)
- 2012-06
- Participants
- 50 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Dulaglutide.
Injections will be separated by a minimum 28-day washout period.
The study will evaluate if the levels of drug in the blood are similar when given by each method.
It had two arms (groups): Manual syringe (active comparator) and Auto-injector (experimental).
The registry classes the interventions as biological.
Who Took Part
Enrollment: 50 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Are overtly healthy males or females, as determined by medical history and physical examination. The method may be one of the following:. Condom with spermicidal agent. Male participant sterilization. True abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable).
The full record lists 14 inclusion and 19 exclusion criteria; among the exclusions: have known allergies to glucagon-like peptide 1 (glp-1) -related compounds including dulaglutide, or any components of the formulation; have family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc; regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
How the Study Was Run
The set-up was randomized, crossover and open-label.
The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Dulaglutide and the comparison in turn, acting as their own control.
Being open-label, the Dulaglutide study did not mask who received what.
It started in 2012-03 with completion listed for 2012-06.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Dulaglutide in 50 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Dulaglutide compound page, all human trials.
Our Notes on the Compound
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.