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Type 2 Diabetes MellitusPhase 2NCT06411275

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

A Phase 2 study testing HTD1801 in people with Type 2 Diabetes Mellitus, run by Shenzhen HighTide Biopharmaceutical Ltd. at 14 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 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. 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
113 participants
Where
14 sitesChina
Study dates
31 Mar 2022to 17 Jan 2023
Phase
Phase 2
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 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Peking University People's Hospital

    Beijing

  • The Second Hospital of Jilin University

    Changchun

  • The First People's Hospital of Changde City

    Changde

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • Huizhou Municipal Central Hospital

    Huizhou

  • Jinan Central Hospital

    Jinan

  • Liaocheng People's Hospital

    Liaocheng

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

  • Nanjing First Hospital

    Nanjing

  • Nanjing Jiangning Hospital

    Nanjing

  • Sir Run Run Hospital Nanjing Medical University

    Nanjing

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang

  • Yan'an University Affiliated Hospital

    Yanan

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

Other trials in China

About this study

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

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.

Read the 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.

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 administered orally BID as two capsules

  • PlaceboDrug

    Matching placebo administered orally BID as two to four capsules

  • HTD1801Drug

    Also called berberine ursodeoxycholate

    HTD1801 administered orally BID as four capsules

Study groups in NCT06411275
Study groupRoleWhat they receive
HTD1801 500 mgExperimentalAdministered orally twice daily (BID)
Receives: Drug: HTD1801
HTD1801 1000 mgExperimentalAdministered orally 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. Mean change in HbA1c

    Mean change in HbA1c from baseline to Week 12

    Measured: 12 Weeks

Secondary outcomes (5)

  1. Mean change in fasting plasma glucose

    Mean change in fasting plasma glucose from baseline to Week 12

    Measured: 12 Weeks

  2. Proportion of patients achieving HbA1c <7.0%

    Proportion of patients achieving HbA1c <7.0% after 12 weeks of treatment

    Measured: 12 Weeks

  3. Proportion of patients achieving HbA1c <6.5%

    Proportion of patients achieving HbA1c <6.5% after 12 weeks of treatment

    Measured: 12 Weeks

  4. Mean change in postprandial glucose

    Mean change in postprandial glucose from baseline to Week 12

    Measured: 12 Weeks

  5. Mean change in low-density lipoprotein cholesterol (LDL-C)

    Mean change in LDL-C from baseline to Week 12

    Measured: 12 Weeks

Timeline

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

  1. First posted13 May 2024
  2. Study start31 Mar 2022
  3. Primary completion17 Jan 2023
  4. Study completion17 Jan 2023

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06411275
Sponsor's protocol ID
HTD1801.PCT103
Status last verified
Jul 2026
First submitted
8 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

Publications

  • Ji L, Ma J, Ma Y, Cheng Z, Gan S, Yuan G, Liu D, Li S, Liu Y, Xue X, Bai J, Wang K, Cai H, Li S, Liu K, Yu M, Liu L. Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e2462185. doi: 10.1001/jamanetworkopen.2024.62185.

    PubMed 40029660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HTD1801 in people with Type 2 Diabetes Mellitus, run by Shenzhen HighTide Biopharmaceutical Ltd. at 14 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 5 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 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Mean change in HbA1c (time frame: 12 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 NCT06411275, 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 3 Aug 2026.

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