The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
This Phase 3 randomized, double-blind, active-controlled, parallel-group study will evaluate the efficacy and safety of HTD1801 compared to dapagliflozin after 24 weeks of treatment. All patients will remain on a stable dose of metformin throughout the study. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 1:1 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
367
HTD1801 1000 mg BID administered orally BID as four capsules
Dapagliflozin 10 mg tablet administered orally QD
Primary Endpoint: Mean change in HbA1c
Mean change in HbA1c from baseline to Week 24
Time frame: 24 Weeks
Mean Change in Fasting Plasma Glucose
Mean change in fasting plasma glucose from baseline to Week 24
Time frame: 24 Weeks
Mean Change in 2-Hour Postprandial Glucose
Mean change in 2-hour postprandial glucose from baseline to Week 24
Time frame: 24 Weeks
Proportion of Patients Achieving HbA1c <7.0%
Proportion of patients achieving HbA1c \<7.0% after 24 weeks of treatment
Time frame: 24 Weeks
Proportion of Patients Achieving HbA1c <6.5%
Proportion of patients achieving HbA1c \<6.5% after 24 weeks of treatment
Time frame: 24 Weeks
Mean Change in Insulin Sensitivity (HOMA-IR)
Mean change in homeostatic model assessment for insulin resistance (HOMA-IR) from baseline to Week 24
Time frame: 24 Weeks
Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Mean change in LDL-C from baseline to Week 24
Time frame: 24 Weeks
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