A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
- Registration Number
- NCT06411275
- Lead Sponsor
- HighTide Biopharma Pty Ltd
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria
- Have followed dietary and exercise interventions for at least 8 weeks prior to screening
- Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
- Have fasting plasma glucose <13.9 mmol/L (screening and pre-randomization)
- Have a body mass index ≥18 kg/m^2 to ≤40 kg/m^2
Key
- Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.)
- Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
- Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening
- Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening
- Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening
- Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
- Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening
- Have used any glucose-modifying medications within 8 weeks prior to screening
- Have had weight gain or loss ≥5% from screening to randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HTD1801 500 mg HTD1801 Administered orally twice daily (BID) HTD1801 1000 mg HTD1801 Administered orally BID Placebo Placebo Administered orally BID
- Primary Outcome Measures
Name Time Method Mean change in HbA1c 12 Weeks Mean change in HbA1c from baseline to Week 12
- Secondary Outcome Measures
Name Time Method Mean change in postprandial glucose 12 Weeks Mean change in postprandial glucose from baseline to Week 12
Proportion of patients achieving HbA1c <7.0% 12 Weeks Proportion of patients achieving HbA1c \<7.0% after 12 weeks of treatment
Proportion of patients achieving HbA1c <6.5% 12 Weeks Proportion of patients achieving HbA1c \<6.5% after 12 weeks of treatment
Mean change in fasting plasma glucose 12 Weeks Mean change in fasting plasma glucose from baseline to Week 12
Mean change in low-density lipoprotein cholesterol (LDL-C) 12 Weeks Mean change in LDL-C from baseline to Week 12
Trial Locations
- Locations (14)
Liaocheng People's Hospital
🇨🇳Liaocheng, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, China
The First People's Hospital of Changde City
🇨🇳Changde, China
Peking University People's Hospital
🇨🇳Beijing, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
The Second Hospital of Jilin University
🇨🇳Chang chun, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
Nanjing Jiangning Hospital
🇨🇳Nanjing, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, China
Yan'an University Affiliated Hospital
🇨🇳Yanan, China
Jinan Central Hospital
🇨🇳Jinan, China
Nanjing First Hospital
🇨🇳Nanjing, China
Sir Run Run Hospital Nanjing Medical University
🇨🇳Nanjing, China