Could a new injection beat insulin for diabetes control?
NCT ID NCT06871761
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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393 people
The number who actually took part.
- Started
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May 2024
- Finished
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May 2025
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, 300400, China