Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic DrugsPhase 3NCT06881264
A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes
A Phase 3 study testing HR17031 injection and insulin glargine in people with Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs
- What is being tested?
- HR17031 injection and insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 19 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75 years at the time of signing the informed consent (both ends included);
- Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included);
- Diagnosed with type 2 diabetes for at least 90 days prior to screening;
- Tested by local laboratory, HbA1c is 7.5%-11% (including both ends);
- Before screening, the daily basal insulin dose had been stabilized at 20-40 U/day (including both ends) for at least 60 days;
- When screening: ① metformin monotherapy stable treatment ≥ 3 months; or ② metformin combined with another OAD for stable treatment for ≥ 3 months; Metformin dose ≥ 1500 mg/day or maximum tolerated dose.
- Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.
Who cannot join
- Known or suspected allergy to the investigational drug product or its components or excipients;
- Systemic glucocorticoid use within 3 months prior to screening;
- Use of weight loss drugs within 3 months prior to screening;
- Received insulin therapy within 1 year prior to screening (excluding short-term therapy [continuous treatment ≤14 days] or insulin therapy for gestational diabetes);
- 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;
- (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
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- Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
- Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
- Known or suspected abuse of alcohol or narcotics;
- Previous history of pancreatitis (acute or chronic);
- 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;
- Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)
The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
- Being tested
- HR17031 injection, insulin glargine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR17031 injectionDrug
HR17031 injection
insulin glargineDrug
insulin glargine
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HR17031 injection | Experimental | Not described Receives: Drug: HR17031 injection |
| Treatment group B: insulin glargine | Experimental | Not described Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c: Changes in HbA1c from baseline to week 26
Measured: week 26
Secondary outcomes (31)
Proportion of subjects achieved HbA1c<7.0% at week 26
Measured: at week 26
Change in body weight from baseline after 26 weeks of treatment
Measured: 26 weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26
Measured: week 26
Actual Daily Insulin dose at week 26
Measured: week 26
Proportion of subjects achieved HbA1c≤6.5% at week 26
Measured: week 26
Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment
Measured: 26 weeks
Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26
Measured: week 26
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
Measured: 12weeks
Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
Measured: 12weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
Measured: at week 26
Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
Measured: at week 26
Proportion of subjects achieved HbA1c<5.7% at week 26
Measured: at week 26
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;
Measured: week 26;
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment
Measured: 26 weeks
Changes in HbA1c from baseline after 52 weeks of treatment
Measured: 52 weeks
Changes in FBG from baseline after 52 weeks of treatment
Measured: 52 weeks
Changes in body weight from baseline after 52 weeks of treatment
Measured: 52 weeks
Proportion of subjects achieved HbA1c<7% at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c≤6.5% at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c<7% without body weight gain at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Measured: at week 52
Proportion of subjects achieved HbA1c<5.7% at week 52
Measured: at week 52
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52
Measured: week 52
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment
Measured: 52 weeks
Actual Daily Insulin dose at week 52
Measured: at week 52
Number of Treatment-emergent Hypoglycemic event from screening to week 53
Measured: from screening to week 53
Number of Treatment-emergent Adverse Events from screening to week 53
Measured: from screening to week 53
Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27
Measured: at week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start30 Apr 2024
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic DrugsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881264
- Sponsor's protocol ID
- HR17031-301
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)
- ClinicalTrials.gov ID
- NCT06881264
- Acronym / sponsor ID
- HR17031-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HR17031 injection | Experimental | Drug: HR17031 injection |
| Treatment group B: insulin glargine | Experimental | Drug: insulin glargine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18-75 years at the time of signing the informed consent (both ends included);
- Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included);
- Diagnosed with type 2 diabetes for at least 90 days prior to screening;
- Tested by local laboratory, HbA1c is 7.5%-11% (including both ends);
- Before screening, the daily basal insulin dose had been stabilized at 20-40 U/day (including both ends) for at least 60 days;
Key exclusion criteria (12 listed)
- Known or suspected allergy to the investigational drug product or its components or excipients;
- Systemic glucocorticoid use within 3 months prior to screening;
- Use of weight loss drugs within 3 months prior to screening;
- Received insulin therapy within 1 year prior to screening (excluding short-term therapy [continuous treatment ≤14 days] or insulin therapy for gestational diabetes);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR17031 injectionHR17031 injection | Drug | Treatment group A: HR17031 injection |
| insulin glargineinsulin glargine | Drug | Treatment group B: insulin glargine |
Primary outcome
Change in HbA1c: Changes in HbA1c from baseline to week 26
Time frame: week 26
31 secondary outcomes
Proportion of subjects achieved HbA1c<7.0% at week 26
Time frame: at week 26
Change in body weight from baseline after 26 weeks of treatment
Time frame: 26 weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26
Time frame: week 26
Actual Daily Insulin dose at week 26
Time frame: week 26
Proportion of subjects achieved HbA1c≤6.5% at week 26
Time frame: week 26
Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment
Time frame: 26 weeks
Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26
Time frame: week 26
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
Time frame: 12weeks
Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
Time frame: 12weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
Time frame: at week 26
Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
Time frame: at week 26
Proportion of subjects achieved HbA1c<5.7% at week 26
Time frame: at week 26
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;
Time frame: week 26;
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment
Time frame: 26 weeks
Changes in HbA1c from baseline after 52 weeks of treatment
Time frame: 52 weeks
Changes in FBG from baseline after 52 weeks of treatment
Time frame: 52 weeks
Changes in body weight from baseline after 52 weeks of treatment
Time frame: 52 weeks
Proportion of subjects achieved HbA1c<7% at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c≤6.5% at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<7% without body weight gain at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
Time frame: at week 52
Proportion of subjects achieved HbA1c<5.7% at week 52
Time frame: at week 52
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52
Time frame: week 52
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment
Time frame: 52 weeks
Actual Daily Insulin dose at week 52
Time frame: at week 52
Number of Treatment-emergent Hypoglycemic event from screening to week 53
Time frame: from screening to week 53
Number of Treatment-emergent Adverse Events from screening to week 53
Time frame: from screening to week 53
Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27
Time frame: at week 27
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HR17031 injection and insulin glargine in people with Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c: Changes in HbA1c from baseline to week 26 (time frame: week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.