← Human Trials & Peer-Reviewed Studies
A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes
Plain-language guide to NCT00612794: phase 1 randomized trial of Exenatide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00612794
- Phase
- phase 1
- Status
- completed
- Start
- 2007-09
- Completion (planned or actual)
- 2008-05
- Participants
- 30 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Exenatide.
A once-weekly version of exenatide is currently being evaluated.
Study GWBW is the first study of exenatide once weekly in Japanese patients.
It had four arms (groups): 1 (experimental), 2 (experimental), 3 (placebo comparator) and 4 (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 30 actual participants took part.
It was open to people of any sex aged from 20 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Body weight ≥50 kg.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: are treated with any exogenous insulin within 3 months of screening; females who are breastfeeding.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
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.
The Exenatide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Exenatide.
Those kept unaware of assignments: participant and investigator.
It started in 2007-09 with completion listed for 2008-05.
It ran at 4 sites in Japan (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus (time frame: 10 weeks).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Exenatide in 30 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.