Chinese researchers have reported promising results from a phase 2 clinical trial evaluating HTD1801, a novel plant-derived medication based on berberine, for treating type 2 diabetes. The study, conducted at Peking University People's Hospital, demonstrates significant improvements in blood glucose control and additional health benefits.
The 12-week randomized trial enrolled 113 patients with type 2 diabetes whose blood glucose levels were inadequately controlled through diet and exercise alone. Participants, with a mean age of 54 years, were divided into three groups receiving either placebo, 500 mg HTD1801 twice daily, or 1,000 mg HTD1801 twice daily.
Significant Glycemic Control Achievements
The trial's primary endpoint focused on reducing glycated hemoglobin (HbA1c), a key marker for long-term blood glucose control. At baseline, participants' mean HbA1c levels were 8.2%. After 12 weeks, the results showed dose-dependent improvements:
- Placebo group: 0.3% reduction
- 500 mg twice daily: 0.4% reduction
- 1,000 mg twice daily: 0.7% reduction
Notably, in the high-dose group, 55.9% of patients achieved HbA1c levels below 7%, and 29.4% reached levels below 6.5%, representing clinically meaningful improvements in diabetes management.
Comprehensive Health Benefits
Beyond glucose control, HTD1801 demonstrated broader health benefits. The medication showed positive effects on:
- Glucose metabolism
- Insulin resistance
- LDL cholesterol levels
- Inflammation markers
- Cardiovascular risk indicators
Importantly, patients did not experience significant weight gain during the treatment period, a common concern with many diabetes medications.
Safety Profile and Tolerability
The drug demonstrated a generally favorable safety profile, though adverse events were observed across all groups:
- 1,000 mg group: 71.1% of patients experienced adverse events
- 500 mg group: 46% reported adverse events
- Placebo group: 39.5% reported adverse events
Most adverse events were mild to moderate, with only four severe cases reported. The researchers noted no clinically significant abnormalities in laboratory tests, vital signs, physical examinations, or electrocardiograms.
Historical Context and Development
HTD1801 (berberine ursodeoxycholate) builds on the traditional use of berberine in Chinese medicine, where it has been employed for centuries to treat various conditions including digestive issues and inflammation. The development of this modern formulation represents a successful translation of traditional medicine into contemporary pharmaceutical applications.
The current trial follows promising results from a 2021 study where HTD1801 showed effectiveness in treating non-alcoholic fatty liver disease while simultaneously improving blood glucose control in type 2 diabetes patients.
The researchers conclude that HTD1801 presents a viable new treatment option for type 2 diabetes, potentially useful either as a standalone therapy or in combination with existing treatments. The comprehensive benefits observed in glycemic control and other metabolic parameters suggest a promising future for this plant-derived medication in diabetes management.
