Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled (Dapagliflozin), Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415773
• Other study ID #: HTD1801.PCT109
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: September 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 dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

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 information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

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

• Have a history of refractory or recurrent urinary tract infections or genital infections

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• HTD1801
HTD1801 1000 mg BID administered orally BID as four capsules
• Dapagliflozin
Dapagliflozin 10 mg tablet administered orally QD

Locations

Country	Name	City	State
China	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	Xuzhou Cancer Hospital	Xuzhou
China	The Second People's Hospital of Yibin	Yibin
China	Yiyang Central Hospital	Yiyang
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

Sponsors (2)

Lead Sponsor	Collaborator
HighTide Biopharma Pty Ltd	Shenzhen HighTide Biopharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint: Mean change in HbA1c	Mean change in HbA1c from baseline to Week 24	24 Weeks
Secondary	Mean Change in Fasting Plasma Glucose	Mean change in fasting plasma glucose from baseline to Week 24	24 Weeks
Secondary	Mean Change in 2-Hour Postprandial Glucose	Mean change in 2-hour postprandial glucose from baseline to Week 24	24 Weeks
Secondary	Proportion of Patients Achieving HbA1c <7.0%	Proportion of patients achieving HbA1c <7.0% after 24 weeks of treatment	24 Weeks
Secondary	Proportion of Patients Achieving HbA1c <6.5%	Proportion of patients achieving HbA1c <6.5% after 24 weeks of treatment	24 Weeks
Secondary	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	Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)	Mean change in LDL-C from baseline to Week 24	24 Weeks