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A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of [amount hidden] Exenatide Once Weekly (Bydureon) in T2DM Patients.
Plain-language guide to NCT02533453: phase 4 interventional trial of Exenatide, 110 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02533453
- Phase
- phase 4
- Status
- completed
- Start
- 2016-01-28
- Completion (planned or actual)
- 2016-12-07
- Participants
- 110 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Exenatide.
It had 1 arm (groups): Bydureon (experimental).
Exenatide once weekly.
The registry classes the interventions as biological.
Who Took Part
110 actual participants took part.
It was open to people of any sex aged from 19 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female, 19-75 years of age. Diagnosed with type 2 diabetes mellitus. Metformin and sulphonylurea. Metformin and thiazolidinedione.
The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:; alpha glucosidase inhibitor or meglitinide within 30 days of screening;; insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-01-28 with completion listed for 2016-12-07.
It ran at 15 sites in South Korea (15).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) (time frame: baseline and 12/24 weeks).
It also tracked 5 secondary outcomes, for example Change in HbA1c, Change in Fasting Plasma Gloucose, Change in Body Weight and Change in Vital Sign.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Exenatide in 110 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
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.