Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New diabetes pill cofrogliptin takes on acarbose in Head-to-Head trial

NCT ID NCT07122102

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called cofrogliptin against an older drug, acarbose, in 200 adults with type 2 diabetes who have never taken diabetes medication. The goal is to see which drug better lowers blood sugar levels and has fewer side effects. Participants will take one of the two drugs and be monitored for changes in blood sugar over time.

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 200 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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 years and older

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.Capable of understanding and voluntarily signing the written informed consent form. 2.Male or female aged ≥18 years (inclusive). 3.Fulfills diagnostic criteria for type 2 diabetes mellitus. 4.Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications. 5.HbA1c at randomization: 7.0% ≤ HbA1c ≤ 9.0%. 6.Fasting plasma glucose (FPG) at randomization: FPG ≤ 11 mmol/L. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg/m². 8.Agrees to maintain consistent dietary and exercise habits throughout the trial period. Exclusion Criteria: * 1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients. 2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic/β-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy. 3.Acute coronary syndrome (STEMI/NSTEMI/unstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent. 4.Congestive heart failure (NYHA Class III-IV). 5.Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). 6.Hepatic impairment: ALT, AST, or ALP \>3×ULN at screening. 7.Severe renal impairment (eGFR \<25 mL/min/1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction/ulceration). 10.Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years. 11.Anti-obesity medications within 3 months prior to consent or weight instability at screening. 12.Malignancy (except basal cell carcinoma) within 5 years and/or active cancer therapy. 13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis/erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia). 16.Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM). 17.Substance abuse within 3 months or chronic conditions potentially compromising compliance. 18.Pregnancy, lactation, or unwillingness to use effective contraception (females/males). 19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Type 2 diabetes are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • He'nan Provincial People's Hospital

    Zhengzhou, Henan, China

More trials for these conditions

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