A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: HTD1801; Drug: HTD1801; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital
  • Chang chun, China
    • The Second Hospital of Jilin University
  • Changde, China
    • The First People's Hospital of Changde City
  • Harbin, China
    • The Fourth Affiliated Hospital of Harbin Medical University
  • Huizhou, China
    • Huizhou Municipal Central Hospital
  • Jinan, China
    • Jinan Central Hospital
  • Liaocheng, China
    • Liaocheng People's Hospital
  • Luoyang, China
    • The First Affiliated Hospital of Henan University of Science and Technology
  • Nanjing, China
    • Nanjing First Hospital
  • Nanjing, China
    • Nanjing Jiangning Hospital
  • Nanjing, China
    • Sir Run Run Hospital Nanjing Medical University
  • Nanyang, China
    • The First Affiliated Hospital of Nanyang Medical College
  • Yanan, China
    • Yan'an University Affiliated Hospital
  • Zhenjiang, China
    • Affiliated Hospital of Jiangsu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Administered orally BID	Drug: Placebo; Matching placebo administered orally BID as two to four capsules
Experimental: HTD1801 500 mg; Administered orally twice daily (BID)	Drug: HTD1801; HTD1801 administered orally BID as two capsules; Other Names: berberine ursodeoxycholate; Drug: HTD1801; HTD1801 administered orally BID as four capsules; Other Names: berberine ursodeoxycholate
Experimental: HTD1801 1000 mg; Administered orally BID	Drug: HTD1801; HTD1801 administered orally BID as two capsules; Other Names: berberine ursodeoxycholate; Drug: HTD1801; HTD1801 administered orally BID as four capsules; Other Names: berberine ursodeoxycholate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in HbA1c	Mean change in HbA1c from baseline to Week 12	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in fasting plasma glucose	Mean change in fasting plasma glucose from baseline to Week 12	12 Weeks
Proportion of patients achieving HbA1c <7.0%	Proportion of patients achieving HbA1c <7.0% after 12 weeks of treatment	12 Weeks
Proportion of patients achieving HbA1c <6.5%	Proportion of patients achieving HbA1c <6.5% after 12 weeks of treatment	12 Weeks
Mean change in postprandial glucose	Mean change in postprandial glucose from baseline to Week 12	12 Weeks
Mean change in low-density lipoprotein cholesterol (LDL-C)	Mean change in LDL-C from baseline to Week 12	12 Weeks

Collaborators and Investigators

• Sponsor: HighTide Biopharma Pty Ltd
• Collaborators: Shenzhen HighTide Biopharmaceutical Ltd.
• Investigators: Study Director: Kui Liu, Shenzhen HighTide Biopharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: HTD1801.PCT103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No