The goal of this clinical trial 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 2 randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of HTD1801 compared to placebo after 12-weeks of treatment. 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 be randomized 1:1:1 to receive HTD1801 500 mg twice daily (BID), HTD1801 1000 mg BID, or placebo BID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
113
Peking University People's Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
Mean change in HbA1c
Mean change in HbA1c from baseline to Week 12
Time frame: 12 Weeks
Mean change in fasting plasma glucose
Mean change in fasting plasma glucose from baseline to Week 12
Time frame: 12 Weeks
Proportion of patients achieving HbA1c <7.0%
Proportion of patients achieving HbA1c \<7.0% after 12 weeks of treatment
Time frame: 12 Weeks
Proportion of patients achieving HbA1c <6.5%
Proportion of patients achieving HbA1c \<6.5% after 12 weeks of treatment
Time frame: 12 Weeks
Mean change in postprandial glucose
Mean change in postprandial glucose from baseline to Week 12
Time frame: 12 Weeks
Mean change in low-density lipoprotein cholesterol (LDL-C)
Mean change in LDL-C from baseline to Week 12
Time frame: 12 Weeks
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The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Huizhou Municipal Central Hospital
Huizhou, China
Jinan Central Hospital
Jinan, China
Liaocheng People's Hospital
Liaocheng, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Nanjing First Hospital
Nanjing, China
Nanjing Jiangning Hospital
Nanjing, China
...and 4 more locations