Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06350890
- 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 diet and exercise alone.
- Detailed Description
This Phase 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety 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 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 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.
Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 408
- Have been diagnosed with Type 2 diabetes mellitus
- Have followed dietary and exercise interventions for at least 8 weeks prior to screening
- If used any glucose-lowering drugs 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 ≥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
Key
- 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 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 Placebo Placebo Administered orally BID HTD1801 HTD1801 Administered orally twice daily (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 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: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) 24 Weeks Mean change in LDL-C from baseline to Week 24
DB Phase: Proportion of patients achieving HbA1c <7.0% 24 Weeks Proportion of patients achieving HbA1c target values of \<7.0% at Week 24
DB Phase: Proportion of patients achieving HbA1c <6.5% 24 Weeks Proportion of patients achieving HbA1c target values 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
Trial Locations
- Locations (56)
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Beijing Pinggu Hospital
🇨🇳Beijing, Beijing, China
Hengshui People's Hospital (Harrison International Peace Hospital)
🇨🇳Hengshui, Hebei, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical College
🇨🇳Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
Zhumadian Central Hospital
🇨🇳Zhumadian, Henan, China
Huangshi Central Hospital
🇨🇳Huangshi, Hubei, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
The First People's Hospital of Changde City
🇨🇳Changde, Hunan, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Yueyang People's Hospital
🇨🇳Yueyang, Hunan, China
Baotou City Central Hospital
🇨🇳Baotou, Inner Mongolia, China
Inner Mongolia Autonomous Region People's Hospital
🇨🇳Hohhot, Inner Mongolia, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Huai'an First People's Hospital
🇨🇳Huai'an, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
The Second Norman Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Tonghua Central Hospital
🇨🇳Tonghua, Jilin, China
Shanghai East Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Qinghai Provincial People's Hospital
🇨🇳Xining, Qinghai, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
🇨🇳Xianyang, Shaanxi, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
The Sixth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
The Third People's Hospital of Datong
🇨🇳Datong, Shanxi, China
People's Hospital of Tianjin
🇨🇳Tianjin, Tianjin, China
The First People's Hospital of Kashgar
🇨🇳Kashgar, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Qiqihar
🇨🇳Qiqihar, Heilongjiang, China
Hebei Petro China Center Hospital
🇨🇳Langfang, Hebei, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
The Second People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Panjin Liaohe Oilfield Gem Flower Hospital
🇨🇳Panjin, Liaoning, China
Yuncheng Central Hospital
🇨🇳Yuncheng, Shanxi, China
Xuancheng People's Hospital
🇨🇳Xuancheng, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Fuwai Hospital, CAMS & PUMC
🇨🇳Beijing, Beijing, China
Handan First Hospital
🇨🇳Handan, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)
🇨🇳Luoyang, Henan, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Sir Run Run Hospital Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China