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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
Plain-language guide to NCT00254254: phase 2 randomized trial of Exenatide, 13 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00254254
- Phase
- phase 2
- Status
- completed
- Start
- 2006-02
- Completion (planned or actual)
- 2007-02
- Participants
- 13 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Exenatide.
It had three arms (groups): Sequence 1 (experimental), Sequence 2 (experimental) and Sequence 3 (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 13 actual participants took part.
It was open to people of any sex aged from 10 years up to 16 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Has a body weight of \>= 50 kg at screening.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening; currently participates in any other interventional study; is currently treated with any of the following excluded medications:.
How the Study Was Run
Design: randomized, crossover and single-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.
Each person switched between Exenatide and the comparison at some point, usually with a gap in between.
In this single-blind Exenatide study one party knew the assignments and the other did not.
Those kept unaware of assignments: participant.
It started in 2006-02 with completion listed for 2007-02.
It ran at 5 sites in United States (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of adverse events (time frame: Visit 2 through Visit 4).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Exenatide in 13 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.