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 diet and exercise alone.
This Phase 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety 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 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 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks. Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
408
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 values 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 values 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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Xuancheng People's Hospital
Xuancheng, Anhui, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
...and 46 more locations