Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353347
• Other study ID #: HTD1801.PCT106
• Status: Recruiting
• Phase: Phase 3
• Start date: November 13, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: HighTide Biopharma Pty Ltd
• Contact: Yi Huang
• Phone: +86 13512789816
• Email: huangyi[@]hightidetx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 555
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HTD1801
HTD1801 1000 mg administered orally BID as four capsules
• Placebo
Matching placebo administered orally BID as four capsules

Locations

Country	Name	City	State
China	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	Chongqing University Three Gorges Hospital	Chongqing
China	The Third People's Hospital of Datong	Datong
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Handan First Hospital	Handan
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin
China	Anhui Provincial Hospital	Hefei
China	The Second Hospital of Anhui Medical University	Hefei
China	Hengshui People's Hospital (Harrison International Peace Hospital)	Hengshui
China	Heze Municipal Hospital	Heze
China	Huai'an First People's Hospital	Huai'an
China	Huangshi Central Hospital	Huangshi
China	Huizhou Municipal Central Hospital	Huizhou
China	Huzhou Central Hospital	Huzhou
China	Jinan Central Hospital	Jinan
China	Jingzhou Central Hospital	Jingzhou
China	Jinzhou Central Hospital	Jinzhou
China	The First People's Hospital of Kashgar	Kashgar
China	Hebei Petro China Center Hospital	Langfang
China	Liaocheng People's Hospital	Liaocheng
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	Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School	Nanjing
China	Nanjing First Hospital	Nanjing
China	Nanjing Jiangning Hospital	Nanjing
China	Sir Run Run Hospital Nanjing Medical University	Nanjing
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing
China	The First People's Hospital of Nanning	Nanning
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang
China	Panjin Liaohe Oilfield Gem Flower Hospital	Panjin
China	The First Hospital of Qiqihar	Qiqihar
China	Shanghai East Hospital of Tongji University	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	The Sixth People's Hospital of Shenyang	Shenyang
China	Shenzhen People's Hospital	Shenzhen
China	The University of Hong Kong - Shenzhen Hospital	Shenzhen
China	Taihe Hospital	Shiyan
China	Siping City Central People's Hospital	Siping
China	The First Affiliated Hospital of Suzhou University	Suzhou
China	People's Hospital of Tianjin	Tianjin
China	Tonghua Central Hospital	Tonghua
China	The Central Hospital of Wuhan	Wuhan
China	Yijishan Hospital of Wannan Medical College	Wuhu
China	The First People's Hospital of Xiangtan City	Xiangtan
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Yanan University Affiliated Hospital	Yanan
China	Yueyang People's Hospital	Yueyang
China	Yuncheng Central Hospital	Yuncheng
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Affiliated Hospital of Jiangsu University	Zhenjiang
China	Zhumadian Central Hospital	Zhumadian
China	Zhuzhou Central Hospital	Zhuzhou
China	Zibo Central Hospital	Zibo
China	The First People's Hospital of Zunyi	Zunyi

Sponsors (1)

Lead Sponsor	Collaborator
HighTide Biopharma Pty Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Open-Label Extension (OLE) Phase: mean change in HbA1c	Mean change HbA1c from baseline to Week 52	52 Weeks
Other	OLE Phase: mean change in 2-Hour postprandial glucose	Mean change in 2-Hour postprandial glucose from baseline to Week 52	52 Weeks
Other	OLE Phase: proportion of patients achieving HbA1c <7.0%	Proportion of patients achieving HbA1c target value of <7.0% at Week 52	52 Weeks
Other	OLE Phase: proportion of patients achieving HbA1c <6.5%	Proportion of patients achieving HbA1c target value of <6.5% at Week 52	52 Weeks
Other	OLE Phase: mean change in insulin sensitivity (HOMA-IR)	Mean change in HOMA-IR from baseline to Week 52	52 Weeks
Other	OLE Phase: mean change in LDL-C	Mean change in LDL-C from baseline to Week 52	52 Weeks
Primary	Primary Endpoint: mean change in HbA1c	Mean change in HbA1c from baseline to Week 24	24 Weeks
Secondary	Double-blind (DB) Phase: mean change in fasting plasma glucose	Mean change in fasting plasma glucose from baseline to Week 24	24 Weeks
Secondary	DB Phase: mean change in 2-hour postprandial glucose	Mean change in 2-hour postprandial glucose from baseline to Week 24	24 Weeks
Secondary	DB Phase: proportion of patients achieving HbA1c <7.0%	Proportion of patients achieving HbA1c target value of <7.0% at Week 24	24 Weeks
Secondary	DB Phase: proportion of patients achieving HbA1c <6.5%	Proportion of patients achieving HbA1c target value of <6.5% at Week 24	24 Weeks
Secondary	DB Phase: mean change in insulin sensitivity (HOMA-IR)	Mean change in homeostatic model Assessment for insulin resistance (HOMA-IR) from baseline to Week 24	24 Weeks
Secondary	DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C)	Mean change in LDL-C from baseline to Week 24	24 Weeks