Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Interventions
- Registration Number
- NCT06415773
- 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 dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
- Detailed Description
This Phase 3 randomized, double-blind, active-controlled, parallel-group study will evaluate the efficacy and safety of HTD1801 compared to dapagliflozin after 24 weeks of treatment. All patients will remain on a stable dose of metformin throughout the study.
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 1:1 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 418
- Have been diagnosed with type 2 diabetes
- Have 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 and ≤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
- Have a history of refractory or recurrent urinary tract infections or genital infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HTD1801 HTD1801 Administered orally twice daily (BID) Dapagliflozin Dapagliflozin Administered orally once daily (QD)
- 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 Mean Change in Fasting Plasma Glucose 24 Weeks Mean change in fasting plasma glucose from baseline to Week 24
Mean Change in 2-Hour Postprandial Glucose 24 Weeks Mean change in 2-hour postprandial glucose from baseline to Week 24
Proportion of Patients Achieving HbA1c <7.0% 24 Weeks Proportion of patients achieving HbA1c \<7.0% after 24 weeks of treatment
Proportion of Patients Achieving HbA1c <6.5% 24 Weeks Proportion of patients achieving HbA1c \<6.5% after 24 weeks of treatment
Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) 24 Weeks Mean change in LDL-C from baseline to Week 24
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
Trial Locations
- Locations (54)
Beijing Pinggu Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Binzhou Medical University Hospital
🇨🇳Binzhou, China
Jilin Province FAW General Hospital
🇨🇳Changchun, China
The Second Norman Bethune Hospital of Jilin University
🇨🇳Changchun, China
The First People's Hospital of Changde City
🇨🇳Changde, China
The First Hospital of Changsha
🇨🇳Changsha, China
The Fourth Hospital of Changsha
🇨🇳Changsha, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, China
Bishan Hospital of Chongqing
🇨🇳Chongqing, China
Deyang People's Hospital
🇨🇳Deyang, China
Handan First Hospital
🇨🇳Handan, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
Huai'an Second People's Hospital
🇨🇳Huai'an, China
Huanggang Central Hospital
🇨🇳Huanggang, China
Huangshi Central Hospital
🇨🇳Huangshi, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, China
Huzhou Central Hospital
🇨🇳Huzhou, China
Jincheng General Hospital
🇨🇳Jincheng, China
Hebei Petro China Center Hospital
🇨🇳Langfang, China
The Second People's Hospital of Lianyungang
🇨🇳Lianyungang, China
Liaocheng People's Hospital
🇨🇳Liaocheng, China
Luoyang Third People's Hospital
🇨🇳Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)
🇨🇳Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)
🇨🇳Luoyang, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, China
Panjin Liaohe Oilfield Gem Flower Hospital
🇨🇳Panjin, China
Pingxiang People's Hospital
🇨🇳Pingxiang, China
The First Hospital of Qiqihar
🇨🇳Qiqihar, China
Sanmenxia Central Hospital
🇨🇳Sanmenxia, China
Huadong Hospital
🇨🇳Shanghai, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, China
Wuhan Third Hospital
🇨🇳Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong Univerity
🇨🇳Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
The First People's Hospital of Xiangtan City
🇨🇳Xiangtan, China
Xiangtan Central Hospital
🇨🇳Xiangtan, China
Xianyang Hospital of Yan'an University
🇨🇳Xianyang, China
Yiyang Central Hospital
🇨🇳Yiyang, China
Xuzhou Cancer Hospital
🇨🇳Xuzhou, China
The Second People's Hospital of Yibin
🇨🇳Yibin, China
Yueyang People's Hospital
🇨🇳Yueyang, China
Shandong Healthcare Group Zaozhuang Central Hospital
🇨🇳Zaozhuang, China
The Second Affiliated Hospital of Zhengzhou
🇨🇳Zhengzhou, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, China
Zhumadian Central Hospital
🇨🇳Zhumadian, China