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CompletedNCT06415773HARMONYUpdated Aug 3, 2026

Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

A Phase 3 interventional study of HTD1801 and Dapagliflozin in T2DM (Type 2 Diabetes Mellitus), sponsored by Shenzhen HighTide Biopharmaceutical Ltd.. Completed at 53 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Shenzhen HighTide Biopharmaceutical Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
367
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • T2DM (Type 2 Diabetes Mellitus)
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 367 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Shenzhen HighTide Biopharmaceutical Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
367 participants (actual)

Study arms

  • Experimental
    HTD1801

    Administered orally twice daily (BID)

    Drug: HTD1801

  • Active comparator
    Dapagliflozin

    Administered orally once daily (QD)

    Drug: Dapagliflozin

Interventions

  • DrugHTD1801

    HTD1801 1000 mg BID administered orally BID as four capsules

    Also known as: Berberine Ursodeoxycholate

  • DrugDapagliflozin

    Dapagliflozin 10 mg tablet administered orally QD

06

What researchers measure

Primary outcomes

  1. Primary Endpoint: Mean change in HbA1c

    Mean change in HbA1c from baseline to Week 24

    Time frame: 24 Weeks

Secondary outcomes

  1. Mean Change in Fasting Plasma Glucose

    Mean change in fasting plasma glucose from baseline to Week 24

    Time frame: 24 Weeks

  2. Mean Change in 2-Hour Postprandial Glucose

    Mean change in 2-hour postprandial glucose from baseline to Week 24

    Time frame: 24 Weeks

  3. Proportion of Patients Achieving HbA1c <7.0%

    Proportion of patients achieving HbA1c \<7.0% after 24 weeks of treatment

    Time frame: 24 Weeks

  4. Proportion of Patients Achieving HbA1c <6.5%

    Proportion of patients achieving HbA1c \<6.5% after 24 weeks of treatment

    Time frame: 24 Weeks

  5. Mean Change in Insulin Sensitivity (HOMA-IR)

    Mean change in homeostatic model assessment for insulin resistance (HOMA-IR) from baseline to Week 24

    Time frame: 24 Weeks

  6. Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Mean change in LDL-C from baseline to Week 24

    Time frame: 24 Weeks

07

Study locations

53 sites
  • Beijing Pinggu Hospital
    Beijing, China
  • Peking University People's Hospital
    Beijing, China
  • Binzhou Medical University Hospital
    Binzhou, China
  • Jilin Province FAW General Hospital
    Changchun, China
  • The Second Hospital of Jilin University
    Changchun, China
  • The First People's Hospital of Changde City
    Changde, China
  • The First Hospital of Changsha City
    Changsha, China
  • The Fourth Hospital of Changsha
    Changsha, China
  • The Second Xiangya Hospital of Central South University
    Changsha, China
  • The Third Xiangya Hospital of Central South University
    Changsha, China
  • Bishan Hospital of Chongqing
    Chongqing, China
  • People's Hospital of Deyang City
    Deyang, China
  • Handan First Hospital
    Handan, China
  • The Fourth Hospital of Harbin Medical University
    Harbin, China
  • The Second People's Hospital of Huai'an
    Huai'an, China
  • Huanggang Central Hospital
    Huanggang, China
  • Huangshi Central Hospital
    Huangshi, China
  • Huizhou Municipal Central Hospital
    Huizhou, China
  • Jincheng General Hospital
    Jincheng, China
  • Hebei Petro China Central Hospital
    Langfang, China
  • The Second People's Hospital of Lianyungang
    Lianyungang, China
  • Liaocheng People's Hospital
    Liaocheng, China
  • Luoyang Third People's Hospital
    Luoyang, China
  • The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)
    Luoyang, China
  • The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)
    Luoyang, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, China
  • Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
    Nanjing, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, China
  • Affiliated Hospital of Nantong University
    Nantong, China
  • The First Affiliated Hospital of Nanyang Medical College
    Nanyang, China
  • Panjin Liaohe Oilfield GEM Flower Hospital
    Panjin, China
  • Pingxiang People's Hospital
    Pingxiang, China
  • The First Hospital of Qiqihar
    Qiqihar, China
  • Sanmenxia Central Hospital
    Sanmenxia, China
  • Huadong Hospital Affiliated to Fudan University
    Shanghai, China
  • Shanghai Sixth People's Hospital
    Shanghai, China
  • Shengjing Hospital of China Medical University
    Shenyang, China
  • The People's Hospital of Liaoning Province
    Shenyang, China
  • Wuhan Third Hospital
    Wuhan, China
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, China
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, China
  • The Central Hospital of Xiangtan
    Xiangtan, China
  • The First People's Hospital of Xiangtan City
    Xiangtan, China
  • Xianyang Hospital of Yan'an University
    Xianyang, China
  • Xuzhou Cancer Hospital
    Xuzhou, China
  • The Second People's Hospital of Yibin
    Yibin, China
  • Yiyang Central Hospital
    Yiyang, China
  • Yueyang People's Hospital
    Yueyang, China
  • Shandong Guoxinyiyang Group Zaozhuang Central Hospital
    Zaozhuang, China
  • The Second Affiliated Hospital of Zhengzhou University
    Zhengzhou, China
  • Affiliated Hospital of Jiangsu University
    Zhenjiang, China
  • Zhumadian Central Hospital
    Zhumadian, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06415773
Lead sponsor
Shenzhen HighTide Biopharmaceutical Ltd.
Responsible party
Sponsor
First posted
May 16, 2024
Start date
Jun 4, 2024
Primary completion
Jun 13, 2025
Completion
Jul 25, 2025
Last update
Aug 3, 2026

Study contacts

Kui Liu, MD
study director · Shenzhen HighTide Biopharmaceutical Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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