The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.
This Phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. 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 modifications, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks. Patients who complete the double-blind treatment phase will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for 28 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
551
Primary Endpoint: mean change in HbA1c
Mean change in HbA1c from baseline to Week 24
Time frame: 24 Weeks
Double-blind (DB) Phase: mean change in fasting plasma glucose
Mean change in fasting plasma glucose from baseline to Week 24
Time frame: 24 Weeks
DB Phase: mean change in 2-hour postprandial glucose
Mean change in 2-hour postprandial glucose from baseline to Week 24
Time frame: 24 Weeks
DB Phase: proportion of patients achieving HbA1c <7.0%
Proportion of patients achieving HbA1c target value of \<7.0% at Week 24
Time frame: 24 Weeks
DB Phase: proportion of patients achieving HbA1c <6.5%
Proportion of patients achieving HbA1c target value of \<6.5% at Week 24
Time frame: 24 Weeks
DB Phase: 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
DB Phase: 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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Baogang Hospital of Inner Mongolia
Baotou, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Luhe Hospital Capital Medical University
Beijing, China
Beijing Pinggu Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Norman Bethune Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
Hunan Provincial People's Hospital
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
...and 54 more locations