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

T2DM (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 Who Have Poor Glycemic Control After Dietary and Exercise Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350890
• Other study ID #: HTD1801.PCT105
• Status: Recruiting
• Phase: Phase 3
• Start date: November 5, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 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 diet and exercise alone.

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 information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 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 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 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
• T2DM (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	Baotou City Central Hospital	Baotou	Inner Mongolia
China	Beijing Pinggu Hospital	Beijing	Beijing
China	Fuwai Hospital, CAMS & PUMC	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	The Second Norman Bethune Hospital of Jilin University	Changchun	Jilin
China	The First People's Hospital of Changde City	Changde	Hunan
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Chongqing University Three Gorges Hospital	Chongqing	Chongqing
China	The Third People's Hospital of Datong	Datong	Shanxi
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Handan First Hospital	Handan	Hebei
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Hengshui People's Hospital (Harrison International Peace Hospital)	Hengshui	Hebei
China	Inner Mongolia Autonomous Region People's Hospital	Hohhot	Inner Mongolia
China	Huai'an First People's Hospital	Huai'an	Jiangsu
China	Huangshi Central Hospital	Huangshi	Hubei
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	The First People's Hospital of Kashgar	Kashgar	Xinjiang
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Hebei Petro China Center Hospital	Langfang	Hebei
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)	Luoyang	Henan
China	The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)	Luoyang	Henan
China	Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	Sir Run Run Hospital Nanjing Medical University	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang	Henan
China	Panjin Liaohe Oilfield Gem Flower Hospital	Panjin	Liaoning
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	The First Hospital of Qiqihar	Qiqihar	Heilongjiang
China	The Third Affiliated Hospital of Qiqihar Medical College	Qiqihar	Heilongjiang
China	Shanghai East Hospital of Tongji University	Shanghai	Shanghai
China	The Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	People's Hospital of Tianjin	Tianjin	Tianjin
China	Tonghua Central Hospital	Tonghua	Jilin
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	The Second Affiliated Hospital of Shaanxi University of Chinese Medicine	Xianyang	Shaanxi
China	Qinghai Provincial People's Hospital	Xining	Qinghai
China	Xuancheng People's Hospital	Xuancheng	Anhui
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yueyang People's Hospital	Yueyang	Hunan
China	Yuncheng Central Hospital	Yuncheng	Shanxi
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Zhumadian Central Hospital	Zhumadian	Henan

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 in 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 values of <7.0% at Week 52	52 Weeks
Other	OLE Phase: Proportion of patients achieving HbA1c <6.5%	Proportion of patients achieving HbA1c target values 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 values of <7.0% at Week 24	24 Weeks
Secondary	DB Phase: Proportion of patients achieving HbA1c <6.5%	Proportion of patients achieving HbA1c target values 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