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New diabetes pill takes on popular drug in Head-to-Head trial

NCT ID NCT06415773

Disease control Sponsor: Shenzhen HighTide Biopharmaceutical Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tested a new drug called HTD1801 (berberine ursodeoxycholate) against the standard diabetes drug dapagliflozin in 367 adults with type 2 diabetes whose blood sugar was not well controlled by metformin alone. The main goal was to see how well HTD1801 lowers blood sugar levels over 24 weeks. The trial is complete, but results have not yet been shared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
berberine ursodeoxycholate (HTD1801)
What this could lead to
If successful, HTD1801 could offer a new oral option for managing blood sugar in people with type 2 diabetes.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. It compares against an existing drug, so it may not prove superior or may have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

367 people

The number who actually took part.

Started

Jun 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

T2DM (type 2 diabetes mellitus)

Contacts and locations

Locations

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, China

  • Affiliated Hospital of Nantong University

    Nantong, China

  • Beijing Pinggu Hospital

    Beijing, China

  • Binzhou Medical University Hospital

    Binzhou, China

  • Bishan Hospital of Chongqing

    Chongqing, China

  • Handan First Hospital

    Handan, China

  • Hebei Petro China Central Hospital

    Langfang, China

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, China

  • Huanggang Central Hospital

    Huanggang, China

  • Huangshi Central Hospital

    Huangshi, China

  • Huizhou Municipal Central Hospital

    Huizhou, China

  • Jilin Province FAW General Hospital

    Changchun, China

  • Jincheng General Hospital

    Jincheng, China

  • Liaocheng People's Hospital

    Liaocheng, China

  • Luoyang Third People's Hospital

    Luoyang, China

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

    Nanjing, China

  • Panjin Liaohe Oilfield GEM Flower Hospital

    Panjin, China

  • Peking University People's Hospital

    Beijing, China

  • People's Hospital of Deyang City

    Deyang, China

  • Pingxiang People's Hospital

    Pingxiang, China

  • Sanmenxia Central Hospital

    Sanmenxia, China

  • Shandong Guoxinyiyang Group Zaozhuang Central Hospital

    Zaozhuang, China

  • Shanghai Sixth People's Hospital

    Shanghai, China

  • Shengjing Hospital of China Medical University

    Shenyang, China

  • The Central Hospital of Xiangtan

    Xiangtan, 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 First Affiliated Hospital of Nanyang Medical College

    Nanyang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Hospital of Changsha City

    Changsha, China

  • The First Hospital of Qiqihar

    Qiqihar, China

  • The First People's Hospital of Changde City

    Changde, China

  • The First People's Hospital of Xiangtan City

    Xiangtan, China

  • The Fourth Hospital of Changsha

    Changsha, China

  • The Fourth Hospital of Harbin Medical University

    Harbin, China

  • The People's Hospital of Liaoning Province

    Shenyang, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The Second Hospital of Jilin University

    Changchun, China

  • The Second People's Hospital of Huai'an

    Huai'an, China

  • The Second People's Hospital of Lianyungang

    Lianyungang, China

  • The Second People's Hospital of Yibin

    Yibin, China

  • The Second Xiangya Hospital of Central South University

    Changsha, China

  • The Third Xiangya Hospital of Central South University

    Changsha, China

  • Wuhan Third Hospital

    Wuhan, China

  • Xianyang Hospital of Yan'an University

    Xianyang, China

  • Xuzhou Cancer Hospital

    Xuzhou, China

  • Yiyang Central Hospital

    Yiyang, China

  • Yueyang People's Hospital

    Yueyang, China

  • Zhumadian Central Hospital

    Zhumadian, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.