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Could a new injection beat insulin for diabetes control?

NCT ID NCT06871761

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This Phase 3 trial tested a new drug called HR17031 against the standard insulin glargine in 393 adults with type 2 diabetes whose blood sugar was not well controlled despite using basal insulin and metformin. The study measured changes in HbA1c (average blood sugar), weight, and safety over 26 weeks. The goal was to see if HR17031 could provide better blood sugar control with fewer side effects like weight gain.

What this could mean

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

Active substance
HR17031 injection (a new drug) compared to insulin glargine (standard insulin)
What this could lead to
If it works, HR17031 could offer better blood sugar control with less weight gain than standard insulin for people with type 2 diabetes.
What could go wrong
This is a Phase 3 trial, but results are not yet published. The new drug may not prove superior or could have unexpected side effects like hypoglycemia.

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

393 people

The number who actually took part.

Started

May 2024

Finished

May 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.

Inclusion Criteria: 1. Male or female, aged 18-75 years at the time of signing the informed consent (both ends included) 2. Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included) 3. Diagnosed with type 2 diabetes for at least 90 days prior to screening 4. Tested by local laboratory, HbA1c is 7.5%-10.5% (including both ends) 5. Before screening, the daily basal insulin dose had been stabilized at 20-40U/ day (including both ends) for at least 60 days 6. Stable treatment with metformin alone or in combination with another OAD for ≥60 days prior to screening. Metformin dose ≥1500 mg/ day or maximum tolerated dose. 7. Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen. Exclusion Criteria: 1. Known or suspected allergy to the investigational drug product or its components or excipients; 2. Systemic glucocorticoid use within 3 months prior to screening 3. Use of weight loss drugs within 3 months prior to screening 4. Insulin therapy other than basal insulin was used within 3 months prior to screening 5. Cardiovascular disease, defined as congestive heart failure (NYHA III-IV), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; And/or coronary, carotid, or peripheral arterial revascularization is planned at screening 6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) 7. Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening; 8. Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate; 9. Known or suspected abuse of alcohol or narcotics; 10. Previous history of pancreatitis (acute or chronic) 11. During pregnancy or lactation;fertile women (WOCBP) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product; 12. Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.

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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.

Contacts and locations

Locations

  • Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University

    Tianjin, Tianjin Municipality, 300400, China