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Can a new pill tame blood sugar in type 2 diabetes?

NCT ID NCT06411275

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This clinical trial is testing an investigational drug called HTD1801 (berberine ursodeoxycholate) to see if it can improve blood sugar control in adults with type 2 diabetes that is not well managed by diet and exercise alone. The study will compare the drug against a placebo over 12 weeks, measuring changes in HbA1c (a long-term blood sugar marker) and other glucose measures. Participants will be randomly assigned to receive either the drug or a placebo, and neither they nor the researchers will know which they are getting. The goal is to determine if this oral medication is safe and effective for helping people with type 2 diabetes achieve better blood sugar levels.

What this could mean

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

Active substance
HTD1801 (berberine ursodeoxycholate), taken orally as capsules
What this could lead to
If successful, this could lead to a new oral medication to help people with type 2 diabetes better manage their blood sugar levels.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not be conclusive or apply to everyone. The drug may also have side effects or fail to show significant benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

113 people

The number who actually took part.

Started

Mar 2022

Finished

Jan 2023

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.

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * 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

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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.

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, China

  • Huizhou Municipal Central Hospital

    Huizhou, China

  • Jinan Central Hospital

    Jinan, China

  • Liaocheng People's Hospital

    Liaocheng, China

  • Nanjing First Hospital

    Nanjing, China

  • Nanjing Jiangning Hospital

    Nanjing, China

  • Peking University People's Hospital

    Beijing, China

  • Sir Run Run Hospital Nanjing Medical University

    Nanjing, China

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

    Luoyang, China

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, China

  • The First People's Hospital of Changde City

    Changde, China

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, China

  • The Second Hospital of Jilin University

    Changchun, China

  • Yan'an University Affiliated Hospital

    Yanan, China

More trials for these conditions

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