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
Mean change in fasting plasma glucose 12 Weeks Mean change in fasting plasma 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 low-density lipoprotein cholesterol (LDL-C) 12 Weeks Mean change in LDL-C from baseline to Week 12
Trial Locations
- Locations (14)
Peking University People's Hospital
🇨🇳Beijing, China
The Second Hospital of Jilin University
🇨🇳Chang chun, China
The First People's Hospital of Changde City
🇨🇳Changde, China
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
Scroll for more (4 remaining)Peking University People's Hospital🇨🇳Beijing, China