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New biweekly diabetes pill could replace daily dosing

NCT ID NCT07198932

Disease control Sponsor: Yanbing Li 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will compare two diabetes medications, cofrogliptin and linagliptin, when added to insulin therapy in Chinese adults with type 2 diabetes. About 594 participants will take either a biweekly or daily pill alongside their usual insulin. Researchers will track blood sugar control, side effects, and other health measures over time.

What this could mean

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

Active substance
cofrogliptin and linagliptin
What this could lead to
If successful, this could show that a biweekly pill (cofrogliptin) works as well as a daily pill (linagliptin) for controlling blood sugar in people with type 2 diabetes who already use insulin.
What could go wrong
This is a real-world observational study, not a controlled trial, so results may be less reliable. It is also limited to Chinese adults, so findings may not apply to other populations.

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.

Participants

About 594 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

Dec 2027

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.

Who is studied

Real-world adult population with type 2 diabetes in China.

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. Sign the informed consent form. 2. Aged ≥18 years. 3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria). 4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total. 5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent. Exclusion Criteria: 1. Allergic to the study drug. 2. Diagnosed with type 1 diabetes. 3. Unable to comply with study-specific procedures. 4. Current or planned pregnant, or currently breastfeeding. 5. With any other situation judged by the investigator, that is unsuitable for participation in this trial.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Affiliated Hospital of Hebei University

    Baoding, China

  • Beijing Luhe Hospital Affiliated to Capital Medical University

    Beijing, China

  • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

    Shanghai, China

  • Shanghai Changzheng Hospital

    Shanghai, China

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, China

  • Xi'an International Medical Center Hospital

    Xi'an, China

  • the First Medical Center of Chinese PLA General Hospital

    Beijing, China

More trials for these conditions

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