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Type 2 Diabetes MellitusPhase 3SYMPHONY-2NCT06353347

Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

A Phase 3 study testing HTD1801 in people with Type 2 Diabetes Mellitus, run by Shenzhen HighTide Biopharmaceutical Ltd. at 64 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 placebo in patients with type 2 diabetes inadequately controlled with metformin. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
HTD1801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
551 participants
Where
64 sitesChina
Study dates
13 Nov 2023to 30 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
  • 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 to ≤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
  • 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

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

China64 sites

  • Baogang Hospital of Inner Mongolia

    Baotou

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Luhe Hospital Capital Medical University

    Beijing

  • Beijing Pinggu Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The Second Norman Bethune Hospital of Jilin University

    Changchun

  • The First People's Hospital of Changde City

    Changde

  • Hunan Provincial People's Hospital

    Changsha

  • The Third Xiangya Hospital of Central South University

    Changsha

  • Chongqing University Three Gorges Hospital

    Chongqing

  • The Third People's Hospital of Datong

    Datong

  • Nanfang Hospital, Southern Medical University

    Guangzhou

  • Handan First Hospital

    Handan

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • Anhui Provincial Hospital

    Hefei

  • The Second Hospital of Anhui Medical University

    Hefei

  • Hengshui People's Hospital (Harrison International Peace Hospital)

    Hengshui

  • Heze Municipal Hospital

    Heze

  • Huai'an First People's Hospital

    Huai'an

  • Huangshi Central Hospital

    Huangshi

  • Huizhou Municipal Central Hospital

    Huizhou

  • Huzhou Central Hospital

    Huzhou

  • Jinan Central Hospital

    Jinan

  • Jingzhou Central Hospital

    Jingzhou

  • Jinzhou Central Hospital

    Jinzhou

  • The First People's Hospital of Kashgar

    Kashgar

  • Hebei Petro China Center Hospital

    Langfang

  • Liaocheng People's Hospital

    Liaocheng

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

    Luoyang

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

    Luoyang

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

    Nanjing

  • Nanjing First Hospital

    Nanjing

  • Nanjing Jiangning Hospital

    Nanjing

  • Sir Run Run Hospital Nanjing Medical University

    Nanjing

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing

  • The First People's Hospital of Nanning

    Nanning

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang

  • Panjin Liaohe Oilfield Gem Flower Hospital

    Panjin

  • The First Hospital of Qiqihar

    Qiqihar

  • Shanghai East Hospital of Tongji University

    Shanghai

  • Shanghai Pudong New Area People's Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • The Sixth People's Hospital of Shenyang

    Shenyang

  • Shenzhen People's Hospital

    Shenzhen

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen

  • Taihe Hospital

    Shiyan

  • Siping City Central People's Hospital

    Siping

  • The First Affiliated Hospital of Suzhou University

    Suzhou

  • People's Hospital of Tianjin

    Tianjin

  • Tonghua Central Hospital

    Tonghua

  • The Central Hospital of Wuhan

    Wuhan

  • Yijishan Hospital of Wannan Medical College

    Wuhu

  • The First People's Hospital of Xiangtan City

    Xiangtan

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Yanan University Affiliated Hospital

    Yanan

  • Yueyang People's Hospital

    Yueyang

  • Yuncheng Central Hospital

    Yuncheng

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

  • Zhumadian Central Hospital

    Zhumadian

  • Zhuzhou Central Hospital

    Zhuzhou

  • Zibo Central Hospital

    Zibo

  • The First People's Hospital of Zunyi

    Zunyi

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.

Read the detailed description

This Phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. 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 modifications, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.

Patients who complete the double-blind treatment phase will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for 28 weeks.

Being tested
HTD1801, Placebo
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 administered orally BID as four capsules

  • PlaceboDrug

    Matching placebo administered orally BID as four capsules

Study groups in NCT06353347
Study groupRoleWhat they receive
HTD1801ExperimentalAdministered orally twice daily (BID)
Receives: Drug: HTD1801
PlaceboPlacebo comparatorAdministered orally BID
Receives: Drug: Placebo

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. Double-blind (DB) Phase: mean change in fasting plasma glucose

    Mean change in fasting plasma glucose from baseline to Week 24

    Measured: 24 Weeks

  2. DB Phase: mean change in 2-hour postprandial glucose

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

    Measured: 24 Weeks

  3. DB Phase: proportion of patients achieving HbA1c <7.0%

    Proportion of patients achieving HbA1c target value of <7.0% at Week 24

    Measured: 24 Weeks

  4. DB Phase: proportion of patients achieving HbA1c <6.5%

    Proportion of patients achieving HbA1c target value of <6.5% at Week 24

    Measured: 24 Weeks

  5. DB Phase: 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. DB Phase: 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 posted9 Apr 2024
  2. Study start13 Nov 2023
  3. Primary completion12 Dec 2024
  4. Study completion30 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
551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353347
Sponsor's protocol ID
HTD1801.PCT106
Acronym
SYMPHONY-2
Status last verified
Aug 2026
First submitted
3 Apr 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ji L, Cheng Z, Ma J, Liu D, Zhang X, Dong X, Lin Y, Yang M, Gan S, Cai H, Wang X, Liu Y, Shi X, Liu K, MacConell L, Yu M, Liu L. HTD1801 in Combination with Metformin for Type 2 Diabetes. NEJM Evid. 2026 Jul;5(7):EVIDoa2500317. doi: 10.1056/EVIDoa2500317. Epub 2026 Jun 7.

    PubMed 42251702

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HTD1801 in people with Type 2 Diabetes Mellitus, run by Shenzhen HighTide Biopharmaceutical Ltd. at 64 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 8 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 11 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 64 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. Some participants in this study may receive a placebo. 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 NCT06353347, which also lists 1 linked publication.

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 11 Aug 2026.

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