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Can a new pill help diabetics with kidney disease control blood sugar?

NCT ID NCT07786571

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing whether dorzagliatin, an experimental oral medication, can improve blood sugar control in people with type 2 diabetes who also have moderate to severe chronic kidney disease. Participants will be randomly assigned to receive either dorzagliatin or linagliptin (an existing diabetes drug) on top of their usual diabetes therapy, including a standardized basal insulin. The study will measure changes in blood sugar levels over 14 weeks, focusing on the time spent in a healthy glucose range, to see if dorzagliatin offers a better option for this challenging patient group.

What this could mean

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

Active substance
Dorzagliatin tablets
What this could lead to
If successful, this could offer a new treatment option for people with type 2 diabetes and advanced kidney disease, potentially improving blood sugar control without worsening kidney function.
What could go wrong
This is an early-stage trial with a relatively small number of participants, and the results may not apply to all patients. There is also a risk that dorzagliatin may not prove more effective than the existing treatment (linagliptin) or may cause unexpected 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 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: 1. Aged 18 to 80 years. 2. Diagnosed with type 2 diabetes mellitus according to the 2026 American Diabetes Association (ADA) criteria or the 2024 Chinese Guidelines for the Prevention and Treatment of Diabetes. 3. Diagnosed with chronic renal insufficiency, with eGFR \<45 mL/min/1.73 m² calculated using the Modification of Diet in Renal Disease (MDRD) equation, and not receiving maintenance dialysis. 4. HbA1c between 7.0% and 9.0%. 5. Receiving a stable antihyperglycemic treatment regimen for at least 4 weeks prior to enrollment. The regimen should include basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are limited to metformin, SGLT2 inhibitors, alpha-glucosidase inhibitors, meglitinides, and TZDs. 6. Written informed consent provided. Exclusion Criteria: 1. Type 1 diabetes mellitus, latent autoimmune diabetes in adults (LADA), or other specific types of diabetes. 2. Diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past 3 months. 3. Active liver disease (ALT/AST \>3 × ULN) or liver cirrhosis (Child-Pugh class B or above). 4. Severe heart failure (NYHA class III-IV) or a history of acute coronary syndrome or stroke within the past 6 months. 5. Malignancy or life expectancy \<6 months. 6. Pregnant or lactating women, or women of childbearing potential not using effective contraception. 7. Known allergy to dorzagliatin or any of its components. 8. Known allergy to linagliptin or any of its components. 9. Current participation in another interventional clinical trial. 10. Mental illness or cognitive impairment preventing compliance with study follow-up. 11. Severe gastrointestinal disease affecting drug absorption. 12. Current use of strong CYP3A4 inducers (e.g., rifampicin) or inhibitors (e.g., ketoconazole) that cannot be discontinued. 13. Severe hypertriglyceridemia (\>5.7 mmol/L). 14. Dialysis for acute renal failure within 3 months before run-in, current dialysis, or need for/planned kidney transplantation within 12 months. 15. Use of corticosteroids or immunosuppressants within the past 6 months. 16. Current use of incretin-based therapies.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 2 diabetes mellitus

As listed by the trial registrant

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

Chronic kidney disease (stages 3B-5) Chronic renal insufficiency Glucose homeostasis Type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

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