Clinical trial NCT06350890: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: HighTide Biopharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint: Mean Change in HbA1c
timeFrame: 24 Weeks
Secondary outcomes:
measure: Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose
timeFrame: 24 Weeks
measure: DB Phase: Mean Change in 2-Hour Postprandial Glucose
timeFrame: 24 Weeks
measure: DB Phase: Proportion of patients achieving HbA1c <7.0%
timeFrame: 24 Weeks
measure: DB Phase: Proportion of patients achieving HbA1c <6.5%
timeFrame: 24 Weeks
measure: DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR)
timeFrame: 24 Weeks
measure: DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 24 Weeks
Other outcomes:
measure: Open Label Extension (OLE) Phase: Mean Change in HbA1c
timeFrame: 52 weeks
measure: OLE Phase: Mean change in 2-Hour Postprandial Glucose
timeFrame: 52 Weeks
measure: OLE Phase: Proportion of patients achieving HbA1c <7.0%
timeFrame: 52 Weeks
measure: OLE Phase: Proportion of patients achieving HbA1c <6.5%
timeFrame: 52 Weeks
measure: OLE Phase: Mean Change in Insulin Sensitivity (HOMA-IR)
timeFrame: 52 Weeks
measure: OLE Phase: Mean Change in LDL-C
timeFrame: 52 Weeks
Locations:
city: Xuancheng
country: China
facility: Xuancheng People's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Pinggu Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital, CAMS & PUMC
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Handan
country: China
facility: Handan First Hospital
state: Hebei
city: Hengshui
country: China
facility: Hengshui People's Hospital (Harrison International Peace Hospital)
state: Hebei
city: Langfang
country: China
facility: Hebei Petro China Center Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: The First Hospital of Qiqihar
state: Heilongjiang
city: Qiqihar
country: China
facility: The Third Affiliated Hospital of Qiqihar Medical College
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhumadian
country: China
facility: Zhumadian Central Hospital
state: Henan
city: Huangshi
country: China
facility: Huangshi Central Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde City
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang People's Hospital
state: Hunan
city: Baotou
country: China
facility: Baotou City Central Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Sir Run Run Hospital Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of Jilin University
state: Jilin
city: Tonghua
country: China
facility: Tonghua Central Hospital
state: Jilin
city: Panjin
country: China
facility: Panjin Liaohe Oilfield Gem Flower Hospital
state: Liaoning
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
state: Liaoning
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Xianyang
country: China
facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital of Tongji University
state: Shanghai
city: Datong
country: China
facility: The Third People's Hospital of Datong
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Tianjin
country: China
facility: People's Hospital of Tianjin
state: Tianjin
city: Kashgar
country: China
facility: The First People's Hospital of Kashgar
state: Xinjiang
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Shenzhen HighTide Biopharmaceutical Ltd.
name: Kui Liu, MD
role: STUDY_DIRECTOR
References: