Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT06353347
- Lead Sponsor
- HighTide Biopharma Pty Ltd
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 551
- Have been diagnosed with type 2 diabetes
- Received a stable dose of metformin monotherapy for at least 8 weeks prior to screening
- If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
- Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization)
- Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
- Have a body mass index ≥19.0 kg/m^2 to ≤35.0 kg/m^2
- Have type 1 diabetes
- Have had any acute diabetic complications within 12 months prior to screening
- Have had any Grade 3 hypoglycemic event within 12 months prior to screening
- Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
- 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 12 weeks prior to screening
- Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
- Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization
- Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HTD1801 HTD1801 Administered orally twice daily (BID) Placebo Placebo Administered orally BID
- Primary Outcome Measures
Name Time Method Primary Endpoint: mean change in HbA1c 24 Weeks Mean change in HbA1c from baseline to Week 24
- Secondary Outcome Measures
Name Time Method DB Phase: proportion of patients achieving HbA1c <7.0% 24 Weeks Proportion of patients achieving HbA1c target value of \<7.0% at Week 24
Double-blind (DB) Phase: mean change in fasting plasma glucose 24 Weeks Mean change in fasting plasma glucose from baseline to Week 24
DB Phase: mean change in 2-hour postprandial glucose 24 Weeks Mean change in 2-hour postprandial glucose from baseline to Week 24
DB Phase: proportion of patients achieving HbA1c <6.5% 24 Weeks Proportion of patients achieving HbA1c target value of \<6.5% at Week 24
DB Phase: mean change in insulin sensitivity (HOMA-IR) 24 Weeks Mean change in homeostatic model Assessment for insulin resistance (HOMA-IR) from baseline to Week 24
DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C) 24 Weeks Mean change in LDL-C from baseline to Week 24
Trial Locations
- Locations (64)
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
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