Table of contents
- Trial overview
- What is being studied
- Who can participate
- Trial design and phase
- Outcomes being measured
- What the trial means for patients
Trial overview
The available trial data describes one interventional study of Sodium Phenylbutyrate in people with type 2 diabetes.[1] The study is authorised and plans to enroll 26 participants.[1]
What is being studied
The trial is titled “Role of BCAA in glucose homeostasis,” which shows that the researchers are studying how boosting BCAA oxidation may affect blood sugar control.[1] The brief summary says the main objective is to see whether prolonged boosting of BCAA oxidation will substantially lower fasting plasma glucose in patients with type 2 diabetes.[1]
The intervention listed is PHEBURANE 483 mg/g granules, given orally at 13 mg/m2.[1] The source data does not give more details about how the treatment is used beyond this study description.[1]
Who can participate
Based on the source data, the target population is patients with type 2 diabetes.[1] No other eligibility details, such as age limits, lab requirements, or exclusion rules, are provided in the trial record.[1]
Trial design and phase
This is a Phase 3 trial.[1] Phase 3 studies usually look at whether a treatment works in patients and continue to collect safety information, but the source data only states the phase and does not give extra design details.[1]
The study is marked as authorised, which means it has regulatory approval to proceed in the setting listed in the source data.[1]
Outcomes being measured
The primary outcome is glucose levels after an overnight fast, expressed in mmol/L.[1] This means the researchers will check blood sugar after the patient has not eaten for a period of time, usually overnight.[1]
The study summary says the goal is to see whether the treatment can lower fasting plasma glucose in patients with type 2 diabetes.[1] No secondary outcomes are listed in the source data.[1]
What the trial means for patients
For patients, this trial is mainly about whether Sodium Phenylbutyrate can help improve blood sugar control in type 2 diabetes.[1] Because the trial is small, with only 26 planned participants, it is focused on early evidence in a limited group rather than broad use.[1]
The study does not provide results yet, so it cannot tell us whether the treatment works.[1] What it does show is the main research question, the target population, the phase, and the blood sugar measure that will be used to judge the effect.[1]
