The Phase 3 clinical trial (NCT06415773) evaluating dapagliflozin against berberine ursodeoxycholate (HTD1801) in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled with metformin completed its primary phase on 2025-06-13. This study aims to assess the efficacy and safety of HTD1801 compared to dapagliflozin.
Background
Dapagliflozin is a medication used in the treatment of Type 2 Diabetes Mellitus. This trial compares its effects to berberine ursodeoxycholate (HTD1801) in a specific patient population to potentially offer new therapeutic insights for individuals whose T2DM is not adequately managed by metformin alone.
Trial design
The study, identified as NCT06415773, is a Phase 3 clinical trial. It enrolled 367 participants diagnosed with Type 2 Diabetes Mellitus (T2DM) who were inadequately controlled with metformin alone. The trial's objective, as stated in its brief summary, is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) when compared to dapagliflozin.
What this means
The primary completion of this Phase 3 trial signifies that data collection for the study's main objectives has concluded. Researchers will now proceed with analyzing the collected data to determine the efficacy and safety profile of berberine ursodeoxycholate (HTD1801) in comparison to dapagliflozin for patients with Type 2 Diabetes Mellitus. The results of this comparison will be important for understanding potential new treatment options for this patient population, especially those who are not adequately controlled with metformin.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06415773, titled "Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin," was updated with the primary completion status on 2025-06-13 on clinicaltrials.gov.