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Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Plain-language guide to NCT00324363: phase 3 randomized trial of Exenatide, 466 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00324363
- Phase
- phase 3
- Status
- completed
- Start
- 2006-01
- Completion (planned or actual)
- 2007-04
- Participants
- 466 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Exenatide.
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.
It had two arms (groups): Exenatide (experimental) and Placebo (placebo comparator).
Placebo in volume equal to exenatide.
The registry classes the interventions as drug.
Who Took Part
466 actual participants took part.
It was open to people of any sex aged from 21 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: have participated in this study previously, or any other study using exenatide or glp-1 analogs; have characteristics contraindicating metformin or sulfonylurea use; have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
How the Study Was Run
The set-up was randomized, parallel-group and double-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.
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 2006-01 with completion listed for 2007-04.
It ran at 14 sites in China (5), Taiwan (4), India (3) and South Korea (2).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Exenatide in 466 people.
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.