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T2DM (Type 2 Diabetes Mellitus)Phase 3HARMONYNCT06415773

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

A Phase 3 study testing HTD1801 and Dapagliflozin in people with T2DM (Type 2 Diabetes Mellitus), run by Shenzhen HighTide Biopharmaceutical Ltd. at 53 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
T2DM (Type 2 Diabetes Mellitus)
What is being tested?
HTD1801 and Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
53 sitesChina
Study dates
4 Jun 2024to 25 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

China53 sites

  • Beijing Pinggu Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Binzhou Medical University Hospital

    Binzhou

  • Jilin Province FAW General Hospital

    Changchun

  • The Second Hospital of Jilin University

    Changchun

  • The First People's Hospital of Changde City

    Changde

  • The First Hospital of Changsha City

    Changsha

  • The Fourth Hospital of Changsha

    Changsha

  • The Second Xiangya Hospital of Central South University

    Changsha

  • The Third Xiangya Hospital of Central South University

    Changsha

  • Bishan Hospital of Chongqing

    Chongqing

  • People's Hospital of Deyang City

    Deyang

  • Handan First Hospital

    Handan

  • The Fourth Hospital of Harbin Medical University

    Harbin

  • The Second People's Hospital of Huai'an

    Huai'an

  • Huanggang Central Hospital

    Huanggang

  • Huangshi Central Hospital

    Huangshi

  • Huizhou Municipal Central Hospital

    Huizhou

  • Jincheng General Hospital

    Jincheng

  • Hebei Petro China Central Hospital

    Langfang

  • The Second People's Hospital of Lianyungang

    Lianyungang

  • Liaocheng People's Hospital

    Liaocheng

  • Luoyang Third People's Hospital

    Luoyang

  • The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)

    Luoyang

  • The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)

    Luoyang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School

    Nanjing

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing

  • Affiliated Hospital of Nantong University

    Nantong

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang

  • Panjin Liaohe Oilfield GEM Flower Hospital

    Panjin

  • Pingxiang People's Hospital

    Pingxiang

  • The First Hospital of Qiqihar

    Qiqihar

  • Sanmenxia Central Hospital

    Sanmenxia

  • Huadong Hospital Affiliated to Fudan University

    Shanghai

  • Shanghai Sixth People's Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • The People's Hospital of Liaoning Province

    Shenyang

  • Wuhan Third Hospital

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Central Hospital of Xiangtan

    Xiangtan

  • The First People's Hospital of Xiangtan City

    Xiangtan

  • Xianyang Hospital of Yan'an University

    Xianyang

  • Xuzhou Cancer Hospital

    Xuzhou

  • The Second People's Hospital of Yibin

    Yibin

  • Yiyang Central Hospital

    Yiyang

  • Yueyang People's Hospital

    Yueyang

  • Shandong Guoxinyiyang Group Zaozhuang Central Hospital

    Zaozhuang

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

  • Zhumadian Central Hospital

    Zhumadian

Other trials in China

About this study

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

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.

Being tested
HTD1801, Dapagliflozin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTD1801Drug

    Also called Berberine Ursodeoxycholate

    HTD1801 1000 mg BID administered orally BID as four capsules

  • DapagliflozinDrug

    Dapagliflozin 10 mg tablet administered orally QD

Study groups in NCT06415773
Study groupRoleWhat they receive
HTD1801ExperimentalAdministered orally twice daily (BID)
Receives: Drug: HTD1801
DapagliflozinActive comparatorAdministered orally once daily (QD)
Receives: Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint: Mean change in HbA1c

    Mean change in HbA1c from baseline to Week 24

    Measured: 24 Weeks

Secondary outcomes (6)

  1. Mean Change in Fasting Plasma Glucose

    Mean change in fasting plasma glucose from baseline to Week 24

    Measured: 24 Weeks

  2. Mean Change in 2-Hour Postprandial Glucose

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

    Measured: 24 Weeks

  3. Proportion of Patients Achieving HbA1c <7.0%

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

    Measured: 24 Weeks

  4. Proportion of Patients Achieving HbA1c <6.5%

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

    Measured: 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

    Measured: 24 Weeks

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

    Mean change in LDL-C from baseline to Week 24

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start4 Jun 2024
  3. Primary completion13 Jun 2025
  4. Study completion25 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06415773
Sponsor's protocol ID
HTD1801.PCT109
Acronym
HARMONY
Status last verified
Jul 2026
First submitted
10 May 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HTD1801 and Dapagliflozin in people with T2DM (Type 2 Diabetes Mellitus), run by Shenzhen HighTide Biopharmaceutical Ltd. at 53 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint: Mean change in HbA1c (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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