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Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
Plain-language guide to NCT00111540: phase 3 interventional trial of Exenatide, 456 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00111540
- Phase
- phase 3
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2006-09
- Participants
- 456 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Exenatide.
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
It had 1 arm (groups): Exenatide (experimental).
The registry classes the interventions as drug.
Who Took Part
456 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: The subject has a body mass index (BMI) of 25 kg/m\^2 to 45 kg/m\^2, inclusive.
The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: is currently treated with certain medications, including exogenous insulin.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Exenatide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2002-11 with completion listed for 2006-09.
It ran at 60 sites in United States (60).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit (time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)). Change in body weight from Visit 1 to each protocol visit (time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)). Change in fasting plasma glucose from Visit 1 to each protocol visit (time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Exenatide in 456 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.