A new plant-based pill significantly improved blood sugar control in type 2 diabetics. Depositphotos and generative AI –
Berberine is a naturally occurring alkaloid found in various plants. It has been used for centuries in traditional Chinese medicine (TCM) to treat digestive issues, inflammation, and bacterial infections.
Researchers from Peking University People’s Hospital in China recently conducted a phase 2 clinical trial assessing the safety and effectiveness of a berberine derivative, berberine ursodeoxycholate, to treat type 2 diabetes (T2D).
T2D is the most common form of diabetes, accounting for around 90% of all diabetics. It is caused by insulin resistance, where the body can’t respond fully to the insulin the pancreas produces, so blood glucose rises (hyperglycemia). Adopting a healthy lifestyle is often the first step in treating T2D, with the aim of preventing disease progression and reducing blood glucose to normal or near-normal levels. If that fails, oral antidiabetic medications can be introduced.
Berberine ursodeoxycholate, or HTD1801, has been evaluated in different clinical studies. In 2021, US researchers conducted a phase 2 clinical trial using it to treat non-alcoholic fatty liver disease. The study participants were also type 2 diabetics, which is commonly associated with this kind of liver disease, and almost all of them were taking oral antidiabetic medications, often two or more at the same time. The researchers found that in addition to reducing liver fat content, HTD1801 significantly improved blood glucose control. Glycated hemoglobin or HbA1c is a blood test that measures average blood glucose levels over the preceding two to three months. It’s the key marker for blood glucose (glycemic) control.
Based on the results of the 2021 study, the present clinical trial aimed to evaluate HTD1801’s effectiveness in patients with T2D alone, whose blood glucose levels had been inadequately controlled with diet and exercise. Trial investigators recruited 113 patients with T2D – the mean age was around 54 – and randomized them to one of three 12-week treatment groups: placebo; 500 mg of HTD1801 twice daily; or 1,000 mg of HTD1801 twice daily.
The study’s primary endpoint was a significant improvement in blood glucose control, as reflected in a reduced HbA1c. At baseline, patients’ HbA1c levels were between 7% and 11% (mean 8.2%), where a normal, non-diabetic HbA1c is below 5.7%. After 12 weeks, the primary endpoint had been achieved. Significant dose-dependent reductions in HbA1c were seen in both HDT1801 treatment groups compared to the placebo group. For the placebo group, the reduction in HbA1c was 0.3%. Those taking 500 mg twice a day saw a reduction of 0.4%, which just pushed it into the realm of statistical significance. However, those on the higher dose of 1,000 mg twice daily had a reduction in HbA1c of 0.7%, a clinically meaningful reduction.
(To read the balance of this very important article please visit: https://newatlas.com/diabetes/berberine-plant-oral-medication-type-2-diabetes/)
The trial was funded by Shenzhen HighTide Biopharmaceutical Ltd, the manufacturers of HTD1801.
The study was published in the journal JAMA Network Open.
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