Clinical trial NCT06415773: Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin
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
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
Collaborators: name: Shenzhen HighTide Biopharmaceutical Ltd.
First posted: 2024-05-16
Enrollment: 418
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 dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint: Mean change in HbA1c
timeFrame: 24 Weeks
Secondary outcomes:
measure: Mean Change in Fasting Plasma Glucose
timeFrame: 24 Weeks
measure: Mean Change in 2-Hour Postprandial Glucose
timeFrame: 24 Weeks
measure: Proportion of Patients Achieving HbA1c <7.0%
timeFrame: 24 Weeks
measure: Proportion of Patients Achieving HbA1c <6.5%
timeFrame: 24 Weeks
measure: Mean Change in Insulin Sensitivity (HOMA-IR)
timeFrame: 24 Weeks
measure: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
city: Changchun
country: China
facility: Jilin Province FAW General Hospital
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of Jilin University
city: Changde
country: China
facility: The First People's Hospital of Changde City
city: Changsha
country: China
facility: The First Hospital of Changsha
city: Changsha
country: China
facility: The Fourth Hospital of Changsha
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Bishan Hospital of Chongqing
city: Deyang
country: China
facility: Deyang People's Hospital
city: Handan
country: China
facility: Handan First Hospital
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Huai'an
country: China
facility: Huai'an Second People's Hospital
city: Huanggang
country: China
facility: Huanggang Central Hospital
city: Huangshi
country: China
facility: Huangshi Central Hospital
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
city: Huzhou
country: China
facility: Huzhou Central Hospital
city: Jincheng
country: China
facility: Jincheng General Hospital
city: Langfang
country: China
facility: Hebei Petro China Center Hospital
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
city: Panjin
country: China
facility: Panjin Liaohe Oilfield Gem Flower Hospital
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Qiqihar
country: China
facility: The First Hospital of Qiqihar
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
city: Shanghai
country: China
facility: Huadong Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
city: Wuhan
country: China
facility: Wuhan Third Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong Univerity
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xiangtan
country: China
facility: The First People's Hospital of Xiangtan City
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
city: Xuzhou
country: China
facility: Xuzhou Cancer Hospital
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
city: Yiyang
country: China
facility: Yiyang Central Hospital
city: Yueyang
country: China
facility: Yueyang People's Hospital
city: Zaozhuang
country: China
facility: Shandong Healthcare Group Zaozhuang Central Hospital
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
city: Zhumadian
country: China
facility: Zhumadian Central Hospital
Study officials:
affiliation: Shenzhen HighTide Biopharmaceutical Ltd.
name: Kui Liu, MD
role: STUDY_DIRECTOR
References: