New pill could help millions with uncontrolled diabetes

NCT ID NCT06350890

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

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

Summary

This Phase 3 trial tested whether HTD1801, a new drug made from a modified natural compound, can lower blood sugar in people with type 2 diabetes who struggle to control it with diet and exercise alone. The study enrolled 408 adults and compared the drug to a placebo over 24 weeks. The main goal was to see if HTD1801 reduces HbA1c, a key measure of long-term blood sugar control.

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)
What this could lead to: If it works, this could provide a new oral medication option to help control blood sugar in people with type 2 diabetes who cannot manage it with diet and exercise alone.
What could go wrong: This is a completed Phase 3 trial, but results are not yet public. Even if effective, it would be one more treatment option, not a cure, and may have side effects or not work for everyone.

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

408 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 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.

Key Inclusion Criteria: * Have been diagnosed with Type 2 diabetes mellitus * Have followed dietary and exercise interventions for at least 8 weeks prior to screening * If used any glucose-lowering drugs 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 ≥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 Key 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 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

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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, Jiangsu, China
Baotou City Central Hospital

Baotou, Inner Mongolia, China
Beijing Pinggu Hospital

Beijing, Beijing Municipality, China
Cangzhou Central Hospital

Cangzhou, Hebei, China
Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China
Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, China
Handan First Hospital

Handan, Hebei, China
Hebei Petro China Central Hospital

Langfang, Hebei, China
Hengshui People's Hospital (Harrison International Peace Hospital)

Hengshui, Hebei, China
Huai'an First People's Hospital

Huai'an, Jiangsu, China
Huangshi Central Hospital

Huangshi, Hubei, China
Huizhou Municipal Central Hospital

Huizhou, Guangdong, China
Hunan Provincial People's Hospital

Changsha, Hunan, China
Huzhou Central Hospital

Huzhou, Zhejiang, China
Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China
Jinan Central Hospital

Jinan, Shandong, China
Jingzhou Central Hospital

Jingzhou, Hubei, China
Liaocheng People's Hospital

Liaocheng, Shandong, China
Liuzhou People's Hospital

Liuzhou, Guangxi, China
Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China
Nanjing First Hospital

Nanjing, Jiangsu, China
Nanjing Jiangning Hospital

Nanjing, Jiangsu, China
Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, Liaoning, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, China
Peking University People's Hospital

Beijing, Beijing Municipality, China
People's Hospital of Tianjin

Tianjin, Tianjin Municipality, China
Pingxiang People's Hospital

Pingxiang, Jiangxi, China
Qinghai Provincial People's Hospital

Xining, Qinghai, China
Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, China
Shenzhen People's Hospital

Shenzhen, Guangdong, China
Sir Run Run Shaw Hospital Nanjing Medical University

Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China
The Central Hospital of Wuhan

Wuhan, Hubei, China
The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)

Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)

Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China
The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
The First Hospital of Qiqihar

Qiqihar, Heilongjiang, China
The First People's Hospital of Changde City

Changde, Hunan, China
The First People's Hospital of Changzhou

Changzhou, Jiangsu, China
The First People's Hospital of Kashi

Kashgar, Xinjiang, China
The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China
The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China
The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, China
The Second Hospital of Jilin University

Changchun, Jilin, China
The Second People's Hospital of Lianyungang

Lianyungang, Jiangsu, China
The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China
The Third Affiliated Hospital of Qiqihar Medical University

Qiqihar, Heilongjiang, China
The Third People's Hospital of Datong

Datong, Shanxi, China
Tonghua Central Hospital

Tonghua, Jilin, China
Xuancheng People's Hospital

Xuancheng, Anhui, China
Yueyang People's Hospital

Yueyang, Hunan, China
Yuncheng Central Hospital

Yuncheng, Shanxi, China
Zhumadian Central Hospital

Zhumadian, Henan, China

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