In short
Clinical trials investigating Sodium Phenylbutyrate are studying its role in people with type 2 diabetes. These studies aim to see whether it can improve glucose control, with a focus on safety and effectiveness in a small patient group. The trial data here describes an interventional Phase 3 study in adults.
Key points
- Clinical trials investigating Sodium Phenylbutyrate in the provided data are focused on type 2 diabetes. The study is a Phase 3 interventional trial with 26 planned participants. Researchers want to see whether the treatment can improve glucose homeostasis and lower fasting blood glucose after an overnight fast. The main outcome is fasting glucose measured in mmol/L. This trial is designed to give more evidence about how the treatment affects blood sugar control in people with type 2 diabetes.
Trial overview
The available trial data describes one interventional study of Sodium Phenylbutyrate in people with type 2 diabetes. The study is authorised and plans to enroll 26 participants.
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. 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.
The intervention listed is PHEBURANE 483 mg/g granules, given orally at 13 mg/m2. The source data does not give more details about how the treatment is used beyond this study description.
Who can participate
Based on the source data, the target population is patients with type 2 diabetes. No other eligibility details, such as age limits, lab requirements, or exclusion rules, are provided in the trial record.
Trial design and phase
This is a Phase 3 trial. 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.
The study is marked as authorised, which means it has regulatory approval to proceed in the setting listed in the source data.
Outcomes being measured
The primary outcome is glucose levels after an overnight fast, expressed in mmol/L. This means the researchers will check blood sugar after the patient has not eaten for a period of time, usually overnight.
The study summary says the goal is to see whether the treatment can lower fasting plasma glucose in patients with type 2 diabetes. No secondary outcomes are listed in the source data.
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. Because the trial is small, with only 26 planned participants, it is focused on early evidence in a limited group rather than broad use.
The study does not provide results yet, so it cannot tell us whether the treatment works. 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.