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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06411275
• Other study ID #: HTD1801.PCT103
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2022
• Est. completion date: January 17, 2023

Study information

• Verified date: May 2024
• Source: HighTide Biopharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• 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 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HTD1801
HTD1801 administered orally BID as two capsules
• Placebo
Matching placebo administered orally BID as two to four capsules
• HTD1801
HTD1801 administered orally BID as four capsules

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
HighTide Biopharma Pty Ltd	Shenzhen HighTide Biopharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

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