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A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
Plain-language guide to NCT00964262: phase 1 randomized trial of Exenatide, 34 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00964262
- Phase
- phase 1
- Status
- completed
- Start
- 2009-08
- Completion (planned or actual)
- 2010-10
- Participants
- 34 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Exenatide.
It had 1 arm (groups): SR Exenatide (PT302) (experimental).
Intervention: Drug: SR Exenatide (PT302).
The registry classes the interventions as drug.
Who Took Part
The registry lists 34 actual participants took part.
It was open to men only aged from 20 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy male subjects aged 20-45 years at screening.
The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus; has a sign or symptom or history related to an acute or chronic pancreatitis; has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on.
How the Study Was Run
Design: randomized, single-group and triple-blind.
Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Blinding on both sides kept the participants and researchers unaware of who received Exenatide.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2009-08 with completion listed for 2010-10.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Exenatide in 34 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.