Clinical trial NCT06411275: A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: HighTide Biopharma Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen HighTide Biopharmaceutical Ltd.
First posted: 2024-05-13
Enrollment: 113
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 trial 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 2 randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of HTD1801 compared to placebo after 12-weeks of treatment.

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 be randomized 1:1:1 to receive HTD1801 500 mg twice daily (BID), HTD1801 1000 mg BID, or placebo BID.

Eligibility criteria: Key Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria
* Have followed dietary and exercise interventions for at least 8 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 ≥18 kg/m\^2 to ≤40 kg/m\^2

Key Exclusion Criteria:

* Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.)
* Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
* Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening
* Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening
* 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 4 weeks prior to screening
* Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
* Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening
* Have used any glucose-modifying medications within 8 weeks prior to screening
* Have had weight gain or loss ≥5% from screening to randomization

Primary outcomes:
measure: Mean change in HbA1c
timeFrame: 12 Weeks
Secondary outcomes:
measure: Mean change in fasting plasma glucose
timeFrame: 12 Weeks
measure: Proportion of patients achieving HbA1c <7.0%
timeFrame: 12 Weeks
measure: Proportion of patients achieving HbA1c <6.5%
timeFrame: 12 Weeks
measure: Mean change in postprandial glucose
timeFrame: 12 Weeks
measure: Mean change in low-density lipoprotein cholesterol (LDL-C)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
city: Chang chun
country: China
facility: The Second Hospital of Jilin University
city: Changde
country: China
facility: The First People's Hospital of Changde City
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
city: Jinan
country: China
facility: Jinan Central Hospital
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
city: Nanjing
country: China
facility: Sir Run Run Hospital Nanjing Medical University
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
city: Yanan
country: China
facility: Yan'an University Affiliated Hospital
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
Study officials:
affiliation: Shenzhen HighTide Biopharmaceutical Ltd.
name: Kui Liu
role: STUDY_DIRECTOR
References: